Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05138302
Recruitment Status : Recruiting
First Posted : November 30, 2021
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

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
Pancreatic Cancer Other: Observation

Layout table for study information
Study Type : Observational
Estimated 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 : April 19, 2021
Estimated Primary Completion Date : April 19, 2023
Estimated Study Completion Date : April 19, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Observation
    This study is an observe research


Primary Outcome Measures :
  1. OS [ Time Frame: 2years ]
    Overall survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients diagnosed with pancreatic cancer
Criteria

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

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): NCT05138302


Locations
Layout table for location information
China, Shanghai
RenJiH Recruiting
Shanghai, Shanghai, China, 200127
Contact: Liwei Wang, Professor    86-21-68385559    lwwang2013@163.com   
Contact: Tiebo Mao, MD       Maotb4@hotmail.com   
Sponsors and Collaborators
RenJi Hospital
Layout table for additonal information
Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT05138302    
Other Study ID Numbers: CPOG2021015
First Posted: November 30, 2021    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases