NCT05138302

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2023

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

October 27, 2021

Last Update Submit

November 17, 2021

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • OS

    Overall survival

    2years

Interventions

ObservationOTHER

This study is an observe research

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients diagnosed with pancreatic cancer

You may qualify if:

  • Patients diagnosed with pancreatic cancer
  • PS score ≤ 2
  • no severe heart, cerebrovascular disease, severe coagulation dysfunction or severe mental disorder

You may not qualify if:

  • PS score \> 2
  • with severe heart, cerebrovascular disease, severe coagulation dysfunction or severe mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RenJiH

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2021

First Posted

November 30, 2021

Study Start

April 19, 2021

Primary Completion

April 19, 2023

Study Completion

April 19, 2023

Last Updated

November 30, 2021

Record last verified: 2021-11

Locations

CN(1)