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Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers

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ClinicalTrials.gov Identifier: NCT05431621
Recruitment Status : Recruiting
First Posted : June 24, 2022
Last Update Posted : June 24, 2022
Sponsor:
Collaborators:
Fudan University
Shanghai Public Health Clinical Center
Xuhui Central Hospital, Shanghai
Shanghai Zhongshan Hospital
Information provided by (Responsible Party):
Singlera Genomics Inc.

Brief Summary:
This is a single blind, case control, multicenter study jointly developed by Zhongshan Hospital of Fudan University, Shanghai Public Health Clinical Center, Shanghai Xuhui Central Hospital, Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University, and Shanghai Singlera Genomics Company. The enrolled population will include positive group, precancerous lesions and healthy control group, which is expected to enroll 2,430 participants. The primary objective is to establish molecular testing methods for non-invasive screening and early diagnosis of digestive system cancers through ctDNA methylation and mutation, cfDNA and ctDNA fragment size, and end motif based model (for esophageal, gastric, colorectal cancer), and through ctDNA methylation detection, ctDNA low-pass WGS, miRNA7 and CTC detection and analysis technology based model (for hepatocellular carcinoma). The sensitivity and specificity of the models in cancer early detection will be evaluated.

Condition or disease
Esophageal Cancer Gastric (Stomach) Cancer Colorectal Cancer Hepatocellular Carcinoma

Detailed Description:
Design of the project: 1) Participants who sign informed consent forms will complete the disease history information collection;2) Collect samples of cancer tissue and corresponding paracancer samples, as well as peripheral blood; 3) Using the MONOD patent detection data of the company's previous research and combining with literature retrieval, to analyze the tissue samples of digestive system cancers to screen the methylation mutation sites;4) ctDNA methylation markers are preliminarily screened by plasma of healthy persons paired with tissues;5) Using the screened blood ctDNA specific methylation markers together with other molecular markers to establish a targeted detection method for early digestive system cancer lesions;6) Retain the most distinguishing targets in the original panel test and establish the second version of the panel;7) Establish and validate predictive models to finalize multitype molecular target detection for peripheral blood DNA;8) Construct statistical learning models based on ctDNA methylation and fragment features, miRNA7™ and CTC, and optimize the models respectively;9) Evaluate the sensitivity and specificity of the models in cancer early detection.

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Study Type : Observational
Estimated Enrollment : 2430 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers
Actual Study Start Date : November 15, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Digestive system cancer group
A total of about 1035 cases are expected to be enrolled, including 432 cases in stage I and 603 cases in II-IV.
Negative group
985 healthy individuals.
High risk group
410 cases with precancerous diseases.



Primary Outcome Measures :
  1. Establish ctDNA-targeted sequencing models for early detection of esophageal, gastric, colorectal and hepatocellular cancer, and evaluate the diagnosis value [ Time Frame: assessed up to 1 year ]
    To discover the characteristic targets of ctDNA methylation, fragment, and mutation in esophageal, gastric, colorectal cancers, and hepatocellular carcinoma, and establish the early detection panel. Then, evaluate the sensitivity and specificity of multi-cancer early detection models.

  2. Establish and evaluate the non-invasive early detection model for hepatocellular carcinoma [ Time Frame: assessed up to 1 year ]
    To establish and evaluate the early detection model for hepatocellular carcinoma based on ctDNA methylation detection, ctDNA low-pass WGS, miRNA7™ and CTC detection.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study aims to enroll 2430 participants from Zhongshan Hospital, Xuhui central hospitial, Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University and Shanghai Public Health Clinical Center.
Criteria

Colorectal cancer, Esophageal cancer and Gastric (stomach) cancer Group

Inclusion Criteria:

  1. Aged 18 to 80, no gender limitation, no pregnant or breastfeeding for women;
  2. Those who can accept gastroscopy and/or total colonoscopy;
  3. Newly-diagnosed patients who had not received surgery, radiotherapy, chemotherapy, targeted therapy or other anti-tumor intervention;
  4. Stop anticoagulant drugs such as warfarin, aspirin, and bolivir for 1 week, and stop low molecular weight heparin that day;
  5. No previous history of other tumor diseases, and no abnormalities in the liver and kidney;
  6. No major trauma requiring blood transfusion treatment within one week.

Exclusion Criteria:

  1. Previous esophageal cancer, stomach cancer, bowel cancer and gastrointestinal adenoma;
  2. Have a history of other cancers;
  3. Systemic inflammatory response syndrome;
  4. Previously experienced esophageal, gastric or colorectal adenoma removal or tumor resection;
  5. Patients with Lynch syndrome in the family;
  6. A history of severe cardiovascular disease (e.g., previous myocardial infarction, coronary artery bypass grafting, coronary stenting, congestive heart failure, myocardial infarction within 6 months, or uncontrolled severe hypertension, etc.) who were deemed unsuitable for inclusion by the investigator;
  7. Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug;
  8. Unsuitable for this trial determined by the researchers;
  9. Failure to collect blood on time according to plan;
  10. The blood sample does not meet the requirements.

Hepatocellular Carcinoma Group

Inclusion Criteria:

  1. Applicable to all enrolled volunteers (1) Aged 18 to 80, no gender limitation, no pregnant or breastfeeding for women; (2) No previous history of malignancy in other sites; (3) To avoid the risk of bleeding caused by taking anticoagulants during sampling, the following provisions shall be made according to different types of samples: stop anticoagulant drugs such as warfarin, aspirin, and bolivir for 1 week, and stop low molecular weight heparin that day; the doctor in charge decides whether to stop anticoagulant drugs before blood draw, according to the specific situation of the volunteers, ; (4) No major trauma requiring blood transfusion treatment within one week;
  2. Only for patients with hepatocellular carcinoma (HCC). (1) Diagnosed with stage I-IV hepatocellular carcinoma; (2) Newly-diagnosed patients with liver cancer, who had not received surgery, radiotherapy, chemotherapy, targeted therapy or other anti-tumor intervention;
  3. Only for high-risk groups (1) Diagnosis of child-Pugh grade A or B, chronic hepatitis B or cirrhosis; (2) No history of liver cancer or malignancy in other sites;
  4. For healthy people only (1) Normal liver function test results on the day of blood collection; (2) No history of hepatitis B, hepatitis C and cirrhosis; (3) No history of liver cancer or malignancy in other sites.

Exclusion Criteria:

  1. Patients with liver cancer who have received surgery, radiotherapy, chemotherapy, targeted therapy;
  2. Cancer patients except HCC, or patients with liver metastasis;
  3. Systemic inflammatory response syndrome;
  4. A history of severe cardiovascular disease (e.g., previous myocardial infarction, coronary artery bypass grafting, coronary stenting, congestive heart failure, myocardial infarction within 6 months, or uncontrolled severe hypertension, etc.) who were deemed unsuitable for inclusion by the investigator;
  5. Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug;
  6. Unsuitable for this trial determined by the researchers;
  7. Failure to collect blood on time according to plan;
  8. The blood sample does not meet the requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05431621


Contacts
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Contact: Xinrong Yang, Doctor 18616881978 yang.xinrong@zs-hospital.sh.cn
Contact: Rui Liu, Doctor rliu@singleragenomics.com

Locations
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China, Shanghai
Xuhui Central Hospital, Shanghai Recruiting
Shanghai, Shanghai, China, 200030
Contact: Dongli He, Master    15001831619    2687204534@qq.com   
Zhongshan Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200030
Contact: Yunshi Zhong, Doctor    13564623481    13564623481@126.com   
Shanghai Public Health Clinical Center Recruiting
Shanghai, Shanghai, China, 201500
Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University Recruiting
Shanghai, Shanghai, China, 201700
Contact: Bin Yan    13916031775      
Sponsors and Collaborators
Singlera Genomics Inc.
Fudan University
Shanghai Public Health Clinical Center
Xuhui Central Hospital, Shanghai
Shanghai Zhongshan Hospital
Investigators
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Study Director: Jian Zhou, Doctor Fudan University
Study Director: Yunshi Zhong, Doctor Fudan University
Principal Investigator: Rui Liu, Doctor Singlera Genomics Inc.
Study Director: Bin Yan, Doctor Shanghai Zhongshan Hospital
Study Director: Dongli He, Master Xuhui Central Hospital, Shanghai
Publications:
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Responsible Party: Singlera Genomics Inc.
ClinicalTrials.gov Identifier: NCT05431621    
Other Study ID Numbers: 2019YFC1315802-01
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singlera Genomics Inc.:
ctDNA markers
DNA methylation
DNA fragment feature
miRNA
CTC
Cancer early detection
Additional relevant MeSH terms:
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Digestive System Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases