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Human Practice
Human Practice
Human Practice (Silver HP)
1 Introduction
At the beginning of the year around March, team Worldshaper-Shanghai is founded through the common acquaintance between students and the team consultants as well as experts in the Shanghai Cancer Institution, whose specialized expertise contributed to the focus of our research—early diagnosis of cancer. What united the team members together, as the common faith held by all team members, is not only the common pursuit of the goal of scientific exploration but also the lofty ideals of assuaging pains and illness of the entire human race.
After the foundation of Worldshaper-Shanghai, the team members have been divided into different groups to launch researches among various types of cancers. Through reading articles, interviewing the experts in the field, and even monitoring the statistics of cancer on a daily basis, the team not only accumulated essential background information among the existing cancer research but also held a comprehensive understanding of cancer in general that helps contribute to the finding of the topic. However, the establishment of the research topic experienced a stage of volatility as the team was not able to find an exact detailed research topic of cancer. Numerous discussions were held within the team as members are reluctant to compromise.
It is not till April that the breakthrough occurred as we focused on our topic of early diagnosis of prostate cancer. During one of the interviews, we were introduced to a report, that emphasized the discrepancy between the growing mortality and morbidity of prostate cancer and the extremely high survival-rate of early-stage prostate cancer. The new discovery of this interesting fact won the unanimous consent of all group members to establish our topic on the early diagnosis of prostate cancer.
2 General background investigation
After we decided to focus on early diagnosis of prostate cancer, we promptly lunch investigations upon the general background of this field. Through investigation, we have noticed that the current diagnosis methods have all different sorts of issues and limitations. For instance, the serum PSA (prostate-specific antigen test), one of the most prevalent tests for prostate cancer diagnosis, demonstrated a not completely reliable result with low sensitivity and specificity, leading to a relatively high rate of misdiagnosis. DRE (digital rectal examination), on the other hand, poses a feeling of shame upon male patients because of how it detects the patient’s private part. Furthermore, the biopsy test might even impose a threat over a patient’s life with severe pain along with the surgery. Therefore, we decided to establish a new way of diagnosis early prostate cancer that aims to be noninvasive, efficient, and highly specific.
In order to actually realize our project and delineate the details, we decided to pay visits to many field experts in urology, whose ideas inspired and helped us to create our plan. While in the meantime, we launched surveys upon the population in different fields friends, and families, aiming to gather the first-handed, genuine belief of the public. While in the meantime of our background investigation, we hosted online-meetups that helped us to seek advice and guidance from other teams in the forms of collaborations.
3 Public Survey
We are planning on designing an initial check kit for people to test themselves for prostate cancer. So that patients can self-test at home or at a community hospital. A public survey allows us to communicate with a variety of people about what their current knowledge of prostate cancer is and whether they would fancy Portable diagnostic devices. Therefore, we design this questionnaire based on the following aspect:
1.The current knowledge and awareness of people toward prostate cancer.
2.Public’s attitude towards portable devices.
3.Male groups attitude and needs toward methods for testing prostate cancer.
We set 7 questions (Q4-Q10) toward the public and another 7 questions (Q11-Q17) specifically towards the male group based on these aspects. We also put skip to some specific questions in order to raise the precision and scientificity of each questionnaire.
We received a total number of 590 samples from people of all ages through online surveys. By collecting and analyzing the questionnaire, we have chosen some important aspects to help us improve our design in order to benefit all people in the future.
3.1 Sample Description
Based on the questionnaire above, we can tell that the age group and gender are evenly distributed (54.92% female, 45.08% male) (28.14% of 25-40 years old, 26.27% 40-50 years old, 20% under 18 years old) with all education background. Mostly undergraduates, about 39.83%.
3.2 Popularity of physical examination
We are aware that the sample’s regular visits to doctors are mostly once every year, about 62.19% do so among 78.14% who take physical examination regularly. The problem that surprises us is that about 21.86% of people did not take physical examination regularly, leaving the potential of late diagnosis. About 17.12% of people take the physical examination once every two years and 5.08% take once every six months.
3.3 Public attitude towards portable healthcare equipment
About half of the data collected had use portable equipment before such as blood pressure meter or glucometer, and 85.25% of people do trust the test result from portable devices. Around 14.75% don’t because of a lack of knowledge about portable devices or don’t trust in the accuracy of the result.
3.4 Prostrate cancer awareness
Surprisingly, there are only a few people who have or whose family and a friend had prostate cancer. Different from the data we found, there is only 4.75%. But we found a possible answer to the next question: only 16.92% of people had participated in the examination of prostate cancer. Since early prostate cancer has almost no symptoms, the small number of a prostate cancer patient in the questionnaire must be inaccurate for there are the possibility of potential patients.
3.5 Public's views on prostate cancer screening
From the chart below, we collect whether they are willing to do a digital rectal examination. Only 43.61% are willing to do so, meaning that the other half dislikes or is still contradict this way of diagnosing prostate cancer. This also shows us a possibility that half of the people will not take the digital rectal examination voluntarily, leading to late diagnosis.
3.6 Public's views on future portable medical equipment for prostate cancer
Compared with examining at the hospital, 86.84% of the people would like to use a portable prostate cancer diagnosis product which is time-saving and easy to operate. People’s concern about purchasing portable diagnostic devices varied. 51.88% of people’s concern about purchasing a portable diagnostic device is the inaccuracy of results. 28.2% are afraid of it to be hard to operate. 31.2% of people are afraid that it would cost too much. In a word, more than half of the respondents are more concerned about the accuracy of new diagnostic equipment than their price and operation process.
In addition, people hold different opinions on the time of receiving the test results. However, we were surprised to find that 21.65% of people would like to wait more than 12-48 hours, which indicates that people are more concerned about the accuracy of the test.
We found that most men's willingness to purchase diagnostic equipment for self-examination ranged from 5 to 10，the average score is 6.82. About 15.41% score 5, meaning that they do accept the kit, but needs time to make sure it’s accurate. 19.92% score it with 8, showing their interest in such devices. 21.05% score it for 10, meaning that they expect the device to be published in the future to be widely used.
3.7 Conclusion
Based on the public survey, these are the problem we found that exists:
1) Regular physical examination is not followed by everyone, leading to potential risks.
2) Since the symptoms for early prostate cancer are almost negligible, it is important to raise people’s alertness and promote them to take an examination of prostate cancer.
3) Most men still feel uncomfortable towards the diagnostic method----- digital rectal examination.
4) A lot of people are not familiar with portable diagnostic devices, leading to distrust of those new technologies.
5) People have lots of concerns about portable devices, including high cost, hard to operate, and most importantly, the accuracy of the result (The most concerning indicators). We noticed a lot of problems through public surveys and sees from a different perspective. We are looking forward to solving these problems through future project development.
4 Expert Interview
In order to understand a more detailed background about prostate cancer and to collect more professional suggestions for our project design, we had several online interviews and one face to face talk with experts from related fields.
Expert list:
Professor Chu - the Deputy Chief Physician from the Urology of Shanghai GongLi Hospital.
Physician Hou - the Chief Physician from the Urology of Shanghai Changhai Hospital.
Doctor Lu - the Technologist-in-charge from Clinical Laboratory of Shanghai East Hospital.
Professor Huang- the Doctoral supervisor from the college of life science and medicine, Zhejiang Sci-Tech University.
4.1 Incidence and symptoms of prostate cancer
Brief summary： ·In China, the middle-aged and elderly men (over 45years old) are the main high-risk population of prostate cancer. ·Early prostate cancer has no special symptoms, which are similar to other prostate diseases. For this reason, they are often ignored by patients.
Through the conversation with Professor Chu and Physician Hou, we got that the incidence of prostate cancer is in the first place in the male urinary system. In China, middle-aged and elderly men (over 45years old) are the main high-risk population for this kind of tumor.The mortality rate of this kind of indolent tumors is not very high, because the course of prostate cancer is very long, its development is also slow. From early-stage to late stage of prostate cancer, it may take several years to more than ten years or more. Physician Hou also told that early prostate cancer has no special symptoms. With the development of prostate cancer, the symptoms of such a tumor are similar to those of benign prostatic hyperplasia (BPH), like frequent urination and poor urination, which have little impact on daily life and cannot cause the attention of male patients. Therefore, there are still very few men who choose to have prostate-related tests.
4.2 Clinical diagnosis and treatment of prostate cancer
Brief summary：
·The most commonly used way to detect prostate cancer is the combination of touch (DRE), medical imaging (CT or MRI), and pathological examination (prostate biopsy).
·Although blood PSA has some disadvantages, it is the main way to detect early asymptomatic prostate cancer nowadays.
·The earlier prostate cancer is found, the higher the cure rate is.
According to Professor Chu and Doctor Lu, there is no convenient and accurate method for prostate cancer detection, the most accurate one is pathological detection: if abnormal prostate is found by digital rectal examination (DRE) or medical imaging (Computed Tomography and Magnetic Resonance Imaging, CT and MRI), it needs to be further confirmed by prostate biopsy, which is cumbersome and usually brings pain to patients. Those statements also confirmed by Physician Hou, he also informed although the sensitivity and specificity of blood PSA are not high enough. it is a commonly used method for early prostate screening method since when other ways (like DRE) find something wrong with the prostate, the prostate is already diseased.
Professor Chu and Professor Chu also introduced the current treatment of prostate cancer. Doctors will consider the actual situation of patients (Imaging features and age, course of the disease, clinical grades) to develop a treatment plan for prostate cancer. The earlier prostate cancer is found, the higher the cure rate is. When the canceration only appears in small tissues, patients can be almost cured by surgery. However, once cancer transferred or the symptoms begin to be serious, only endocrine therapy can be used to alleviate it, which often causes drug resistance in the human body.
4.3 Public's awareness of prostate cancer
Brief summary：
·More efforts are needed to promote social and individual awareness of prostate health
For people’s awareness, Professor Chu points out a fact that people over 50 years old, who belong to the high incidence of prostate cancer, do not have a strong awareness of prostate health. So, doctors should remind them to test blood PSA repeatedly. In contrast, people under the age of 45 have relatively weak awareness of physical examination because they usually feel that they are not high-risk people. Moreover, many patients know very little about prostate cancer, they don't know how harmful prostate cancer is and how to protect themselves from prostate cancer. Although there are some options to detect prostate and rectum in the current physical examination, some people still refuse to choose for various reasons. Fortunately, Physician Hou said, with the improvement of physical examination service in China, more and more men will get prostate examination in the annual examination or company physical examination. It is a general trend that more people pay attention to prostate health problems.
4.4 Suggestions for the development of urine diagnostic methods
Brief summary：
·To detect RNA biomarkers in urine, it is necessary to consider how to prevent RNA degradation in the urine. Morning urine is the most suitable urine sample.
·Simple and accurate kits are very popular in the field of clinical detection.
·Our kit design has got comprehensive guidance from Professor Huang in various aspects, like reagents, consumables, packaging, process, quality control, and so on.
4.4.1 The feasibility of urine as a test sample for prostate cancer
Doctor Lu motioned that urine is certainly the most ideal one in the noninvasive sample, but there are no particularly good indicators in urine for clinical testing because there are many factors affecting the content of urine substances, such as the amount of drinking water before the examination, the daily work and rest and living habits of patients.
Professor Hou provided a useful suggestion to this problem: He said we should take first-morning urine, especially the urine obtained after massaging the prostate because the prostate massage can increase the level of prostate secretion in the urine.
Doctor Lu and Professor Huang also emphasized that RNA in urine is easy to degrade, and we need to verify the time required for urine samples from sampling to testing. It is also necessary to find a suitable method for urine sample preservation, which makes the detection time more flexible.
4.4.2 Clinical requirements for urine diagnostic kit
Simple and accurate kits are very popular in the field of clinical detection, Doctor Lu said. He emphasized that we need to ensure the specificity of our biomarker to prostate cancer. To ensure the sensitivity of the detection, we need to determine the concentration range of the biomarkers that our method can detect, which should also correspond to the content of biomarker in patients’ urine whether this range corresponds to the biomarker in the urine of prostate cancer patients., Moreover, how to avoid misdiagnosis (such as causing false positive or false negative) is also a problem we should consider.
4.4.3 The design of urine diagnostic kit
Before we met Professor Huang, we knew very little about the diagnostic kits.
Our first interview was before we started the applied design, we mainly understood the general situation of the diagnostic kits on the market through this conversation:
The design of the kit generally needs to ensure that this technology functions normally and stably outside of the experimental conditions. A product needs to be tested for months or even years before it goes on the market to improve the stability and accuracy of the product. More importantly, the production of kits must pass relevant national regulations.
Most kits now include various consumables and do not need to be sealed, but need to be careful of leakage. The materials in the kit can be purchased from different suppliers or customized. The general shelf life of test reagents is at least one year.Generally, a manual should be provided to users. Some professional test kits like our future product require trained personnel to operate to ensure the normal use of the product.
Besides, a good reference (positive control and negative control) can not be ignored since our design uses the color output generated by a fluorescent protein. Color cards or color recognition devices can help users to identify results more prepared.
After we finished the script of our applied design, we had our second interview with Professor Huang. We presented our applied design, experiment result, and some tentative ideas to Professor Huang, he made some valuable suggestions for our portable kit and introduced several factories and prices of the materials we need.
For producing a portable kit, Professor Huang suggested that it is usually a lunch box size. We should add a negative control and a positive control because there may be mistakes in manual operation.
To transport and store, the preservative can be instead by dry ice bag for short period storage under a certain temperature like 8°C or -20°C. For low-temperature storage, choose the thickness of the cardboard and the waterproof material will prevent it from getting soaked and rotten during transportation.
To collect sample urine, a tube with scale and cap is needed. When we asked if we can use a dropper to preserve certain solutions, he preferred test tubes because they can be sealed.
Because we changed the users of the kits to trained personnel in community hospitals or physical examination centers, we will consider how to coordinate the products with the hospital equipment and reduce the cost. Generally speaking, the testing rooms in community hospitals or physical examination centers are equipped with pipettes, centrifuges, and metal heaters that all need by our kit. As a result, we don't need to produce these tools extra. Besides, a portable magnetic separator is the only one we need to provide for users in the case that some community medical centers didn’t have one.
Finally, Professor Huang pointed to note about our future work. He hoped that we would focus on improving details, such as disturbing factors of the patients’ urine and hospital informed consent.
We are honored to interview each expert and thankful for their suggestions.
5 Online Meetup
On August 4th, we co-hosted an online iGEM meetup with ASTWS-China. In the online meetup, six teams across China presented their projects and received valuable suggestions from instructors, fellow iGEMers, as well as guests invited to this meetup, which include iGEM ambassador Jeff Hu. As for us, we gained insight into the topic of urine ethics and recognized potential problems for using urine from patients.
Integrated Human Practices(Gold HP)
There are mainly three parts to our integrated human practices: improvements to our project, our applied design, and our public engagement. Much of the improved works resulted from our interviews with various experts, as well as our background investigation.
1 Research Project
1.1 Urine Ethics: On an online meetup, iGEM ambassador Jeff Hu emphasized the importance of urine ethics and urine safety. In fact, as we were designing our experiments, we discovered that it is difficult to acquire access to urine from patients, as it would require a permit from both the hospital and the patients. Thus, we were open to using replacements of urine, such as artificially-synthesized urine or animal urine. Later, we wrote an email to the iGEM safety committee and received the official requirements. The expert's feedback in expert interviews also played a very important role in guiding us.
At last, we discovered we could purchase artificially-synthesized urine, thus settling this problem, and updated our safety form.
1.2 Sample Collection: Based on our background research, we gained new insights for the collection of urine samples in the future:
1) Urine samples for testing should be collected on-site. We have to look for the possibilities of self-testing and testing at physical examination centers.
2) There is a sufficient amount of RNA biomarker molecules present in the first-morning urine.
3) It is possible to add preservatives to the urine sample to maintain RNA stability.
2 Implementation
Through our interview with professor Huang, we improved our Kit design by making it more convenient and more professional. Also, we determined the users of the testing kit as the examinees in community hospitals or physical examination centers. Some equipment ( pipettes, centrifuges, and metal heaters) were removed from our design since they are the common equipment in community hospitals or physical examination centers.
3 Public Engagement
Through our public surveys and interview with Professor Chu and Physician Hou, we discovered that the general public is not aware of the fact that prostate cancer at its early stages can be cured. Also, people have low awareness about the importance of testing for prostate cancer. Therefore, one main focus of our public engagement is education about the significance of prostate cancer and its testing.
