Support for Early Cancer Detection
How to Apply for the First Open Application (lung adenocarcinoma, serum or plasma)
- Support Content
- Application Conditions
- Support Conditions
- How to Apply
- Contact Information
- Schedule (tentative)
Non-small-cell lung cancer requires an early diagnosis due to its poor outcome when cleavage at operation is impossible. If the early diagnosis by blood test becomes possible, we can expect the decrease in the mortality rate in non-small-cell lung cancer.
In view of the above, our group will focus on the most prevalent tissue-type lung adenocarcinoma among non-small-cell lung cancers.
We will provide biospecimen (and its control biospecimen) to the research groups trying to conduct early-cancer detection using blood specimen (blood serum or plasma). Our support includes providing biospecimen and its controls that were collected, frozen, and stored prior to the diagnosis of cancer to support finding the biomarkers to detect the cancer in the early stage.
However, our support limits to research groups that obtained the Grant-in-aid for Scientific Researches funded by MEXT (hereinafter referred to as “KAKENHI”), Japan, for the research on the biomarkers.
We will provide biospecimen about 30 new cases and about 60 of its controls which were diagnosed as lung adenocarcinoma within three years after the baseline survey of The Japan Multi-Institutional Collaborative Cohort Study (hereinafter referred to as “J-MICC research”).
|Case details||The cases are from patients diagnosed as lung adenocarcinoma whose blood has been collected after six months or more and less than three years after the baseline survey. We provide the tissues (obtained by biopsy or operation) that have been diagnosed as specific diseases. Please refer the terms between the diagnosis, and the progress to the attached documents. (In some cases, the provided biospecimen could be slightly different) We exclude the patients who had been diagnosed as cancer at the time of the baseline survey.|
|Control details||Please select two controls with the following variables:
2) Age at the time of the baseline survey (five-year-intervals: 35-39, 40-44 … 65-69 years old)
3) Surveyed area
4) Surveyed year (every year)
We exclude the data of patients who had been diagnosed as cancer before the baseline survey, according to the questionnaire. We include the data of patients who do not recognize the cancer symptom during the observation period of three years after the baseline survey.
|Collateral Information||Case or control, sex, Age (at the time of the baseline survey), examined date, terms between blood collection and diagnosis, cancer part (e.g. upper lobe of the lung), tissue type, progress of cancer (before or after the operation, intraepithelial, confined in the organ, metastasis of the lymph node, infiltration of the nearby organ, distant metastasis, or unknown), smoking history, fasting hours to the blood collection, hours from blood collection to make the blood frozen.
In principle, we will provide the details of the information above to the support users after the biomarker has been measured, for an objective measurement. (Please contact us if you need it prior to the measurement.) If the applicant need the information as a control to set the measurement condition, please inform the support provider that the minimum cases (two to three) are subject to control prior to the measurement.
|Details of blood specimen (blood serum or plasma)||The blood specimen had been dispensed 300 μl per case in the first place. Subsequently, it need to be melted and dispensed to the appropriate amount for use, and frozen again. Those biomarkers venerable to re-freeze are hardly accepted. If the applicant had a specific container (tube or plate) to use, the applicant must send them to J-MICC office to let the person in charge at J-MICC dispense in these containers. If no specific container is requested, the central office will dispense the specimen into general microtubes.|
Please read the following qualifications and descriptions in advance to fill in the application form.
- Applicant must have already adopted FY2017 KAKENHI (Grant-in-aid, MEXT, principle investigator or co-investigator) on the topic of development of the biomarkers.
- Applicant must confirm the biomarker’s sensibility and the specificity by using more than 30 cases of human lung adenocarcinoma and more than ten cases of the human controls.
- Applicant can agree to conduct the joint research with J-MICC, under the conditions below.
- Please note that any party in J-MICC study including the members in J-MICC Office or the early-cancer-detection committee will keep the information obtained by application documents or support activities confidential.
- Applicant must include the five researchers belonging to J-MICC study as one of the authors in the academic paper upon publication.
- Applicant can apply less than 300ul of the blood samples per case of lung adenocarcinoma/control. The less amount is needed, the more the application is likely accepted.
- For objective purpose, the applicant will not be informed of the distinction between the lung adenocarcinoma and its controls when the samples were provided. If the applicant need to know the distinction for setting up the measurement conditions, the support provider will inform the support user of the controls prior to the measurement.
- The accepted support user must have the ethical approval at their affiliated organizations. J-MICC office has already taken the ethical approval.
- The accepted support user will submit the measured value of the biomarker to the Central Office, subsequently, the Central Office will provide the support users of the information about the calculated sensitivity and specificity, as well as the collateral information stated above.
- The measured value of the biomarkers submitted to the Central Office (Support Condition No.6) belong to the support user will be disposed at the J-MICC Office in the end of the research period. J-MICC office will not charge fee for the support although the fee may be charged in the future.
- J-MICC office will not claim any intellectual property rights created by the support program.
Please fill in and send the form (Support for Early Cancer Detection) on this platform’s website. The quantity of the required blood per sample (blood serum, plasma, or either) should be filled in.
Applicants are not obliged to write about the detail of the measured items (biomarkers) if it does not affect the screening process.
However, the sensitivity and specificity must be stated in the application form: the sensitivity means the ratio and the number of the positive cancer case, and the specificity means the ratio and the number of the negative control case). The applicant can send other information relating to the application to the Administrative Office of Platform of Supporting Cohort Study and Biospecimen Analysis. (see below)
Office of Platform of Supporting Cohort Study and Biospecimen Analysis may request additional information for examining the applications.
Platform of Supporting Cohort Study and Biospecimen Analysis
Support by providing biological resources and data from a cohort study in a general population.
Mariko Naito (Co-investigator), Takeshi Wakai (Co-investigator)
Tel: 052-744-2132, email: email@example.com
September 15: Open for Application
October 31: Application Closed
November 1 — November 30: Examination of the Early Cancer Detection
December 1 (scheduled): Notification of the results
Upon obtaining the ethical approval at the support user’s affiliated organization, we will start providing the biospecimen.