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Development and establishment of early screening platform for pancreatic cancer based on Next Generation Sequencing(NGS) technologies

Development and establishment of early screening platform for pancreatic cancer based on Next Generation Sequencing(NGS) technologies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078109
Enrollment
Unknown
Registered
2023-11-29
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer

Interventions

Gold Standard:NCCN
Index test:Targeted pancreatic cancer susceptibility gene sequencing panel design

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients with pancreatic cancer should meet the following criteria to be enrolled in the trial: 1. age =18 and =90 years with pancreatic cancer, regardless of gender; 2. Peripheral blood can be obtained; 3. ECOG 0~2 points; 4. Subjects voluntarily participate and sign the informed consent; 5. No serious hematologic, cardiac, pulmonary functional abnormalities and immunodeficiencies (refer to the respective criteria); 6. Ability to comply with the study visit plan and other protocol requirements. High-risk individuals should meet the following criteria to be enrolled in the trial: 1. Presence of known pancreatic cancer susceptibility genes such as ATM, BRCA1, BRCA2, CDKN2A, MLH1, MSH2, MSH6, EPCAM, PALB2, STK11, TP53 and other pathogenic and/or probable germline mutations, as well as the presence of a family history of pancreatic cancer (first-degree or second-degree relatives) associated with germline pathogenic or probable pathogenic mutations; 2. People with 2 or more first-degree relatives in the family with pancreatic (even in the absence of a known pathogenic/probably pathogenic germline mutation); 3. People with a family history of pancreatic cancer in 3 or more first- (or) second-degree relatives (even in the absence of a known pathogenic/probably pathogenic germline variant).

Exclusion criteria

Exclusion criteria: 1. The histologic pattern does not meet the pathological diagnostic criteria of pancreatic ductal adenocarcinoma; 2. Any other medical conditions and social/psychological problems, etc., which are judged by the investigator to be unsuitable for participation in the initial collection of information on the enrolled population.

Design outcomes

Primary

MeasureTime frame
Positive predictive value;Negative expected value;specificity;sensitiveness;consistence;Kappa value;

Countries

China

Contacts

Public ContactYu Xianjun

Fudan University Shanghai Cancer Center

yuxianjun@fudanpci.org+86 181 2129 9331

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026