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A Clinical Study of BRCA and DNA Damage Repair Genes in Blood Samples of Chinese Pancreatic Cancer Patients

Sponsor
RenJi Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05138302
Collaborator
(none)
1,000
Enrollment
1
Location
24
Anticipated Duration (Months)
41.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to know the status of BRCA and DDR genes in PDAC patients in China. Peripheral venous blood samples of the patients will be collected for next-generation sequencing of BRCA and DNA damage repair related genes. At the same time, it is necessary to record clinical information such as age, gender, tumor pathological type, tumor stage and grade, whether surgery is performed, the size of postoperative residual lesions, and treatment methods. Prognostic indicators include the association of factors such as PFS, ORR, and DCR are also recorded.

Condition or Disease Intervention/Treatment Phase
  • Other: Observation

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Multicenter Clinical Study of BRCA and DNA Damage Repair Genes in Blood Samples of Chinese Pancreatic Cancer Patients
Actual Study Start Date :
Apr 19, 2021
Anticipated Primary Completion Date :
Apr 19, 2023
Anticipated Study Completion Date :
Apr 19, 2023

Outcome Measures

Primary Outcome Measures

  1. OS [2years]

    Overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients diagnosed with pancreatic cancer

  • PS score ≤ 2

  • no severe heart, cerebrovascular disease, severe coagulation dysfunction or severe mental disorder

Exclusion Criteria:

  • PS score > 2

  • with severe heart, cerebrovascular disease, severe coagulation dysfunction or severe mental disorder

Contacts and Locations

Locations

Site City State Country Postal Code
1 RenJiH Shanghai Shanghai China 200127

Sponsors and Collaborators

  • RenJi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RenJi Hospital
ClinicalTrials.gov Identifier:
NCT05138302
Other Study ID Numbers:
  • CPOG2021015
First Posted:
Nov 30, 2021
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pancreatic Neoplasms

Study Results

No Results Posted as of Nov 30, 2021