Colorectal Cancer Clinical Trial
Official title:
Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers
Verified date | January 2023 |
Source | Singlera Genomics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2430 |
Est. completion date | July 31, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai |
China | Shanghai Public Health Clinical Center | Shanghai | Shanghai |
China | Xuhui Central Hospital, Shanghai | Shanghai | Shanghai |
China | Zhongshan Hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Singlera Genomics Inc. | Fudan University, Shanghai Public Health Clinical Center, Shanghai Zhongshan Hospital, Xuhui Central Hospital, Shanghai |
China,
Chen X, Gole J, Gore A, He Q, Lu M, Min J, Yuan Z, Yang X, Jiang Y, Zhang T, Suo C, Li X, Cheng L, Zhang Z, Niu H, Li Z, Xie Z, Shi H, Zhang X, Fan M, Wang X, Yang Y, Dang J, McConnell C, Zhang J, Wang J, Yu S, Ye W, Gao Y, Zhang K, Liu R, Jin L. Non-invasive early detection of cancer four years before conventional diagnosis using a blood test. Nat Commun. 2020 Jul 21;11(1):3475. doi: 10.1038/s41467-020-17316-z. — View Citation
Guo S, Diep D, Plongthongkum N, Fung HL, Zhang K, Zhang K. Identification of methylation haplotype blocks aids in deconvolution of heterogeneous tissue samples and tumor tissue-of-origin mapping from plasma DNA. Nat Genet. 2017 Apr;49(4):635-642. doi: 10.1038/ng.3805. Epub 2017 Mar 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Establish ctDNA-targeted sequencing models for early detection of esophageal, gastric, colorectal and hepatocellular cancer, and evaluate the diagnosis value | 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. | assessed up to 1 year | |
Primary | Establish and evaluate the non-invasive early detection model for hepatocellular carcinoma | To establish and evaluate the early detection model for hepatocellular carcinoma based on ctDNA methylation detection, ctDNA low-pass WGS, miRNA7™ and CTC detection. | assessed up to 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |