CIrculating Tumor DNA for Monitoring Response to First Line Chemotherapy in Unresectable PANcreatic Cancer
KRAS (Kirsten Rat Sarcoma) Mutant CIrculating Tumor DNA for Monitoring Response to First Line Chemotherapy in Locally Advanced and Metastatic PANcreatic Cancer
1 other identifier
interventional
69
0 countries
N/A
Brief Summary
With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem. The aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated KRAS ctDNA (circulating tumor DNA) in unresectable metastatic or locally advanced pancreatic adenocarcinomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pancreatic-cancer
Started Apr 2016
Typical duration for not_applicable pancreatic-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2019
CompletedFirst Submitted
Initial submission to the registry
September 5, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2020
CompletedSeptember 23, 2020
September 1, 2020
3.2 years
September 5, 2020
September 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation of the ctDNA level to the response to chemotherapy
Response to chemotherapy was evaluated with RECIST criteria 1.1 on the first CT scan
3 months
Secondary Outcomes (2)
Overall survival
6 months after last patients inclusion
Progression free survival
6 months after last patients inclusion
Study Arms (1)
Only arm
EXPERIMENTALBlood samples to analyze ctDNA
Interventions
Eligibility Criteria
You may qualify if:
- Proven pancreatic adenocarcinoma (histology or cytology)
- Metastatic or locally advanced unresectable
- With thoraco-abdomino-pelvic scanner less than a month old
- Chemotherapy treatment regardless of the protocol
- Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party
- Informed consent signed by the patient after clear and fair information about the study
You may not qualify if:
- Linguistic or psychological refusal or inability to understand and / or sign the informed consent
- Patient who has already received chemotherapy or radiotherapy for pancreatic cancer.
- Immediately resectable tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Evrard C, Ingrand P, Rochelle T, Martel M, Tachon G, Flores N, Randrian V, Ferru A, Haineaux PA, Goujon JM, Karayan-Tapon L, Tougeron D. Circulating tumor DNA in unresectable pancreatic cancer is a strong predictor of first-line treatment efficacy: The KRASCIPANC prospective study. Dig Liver Dis. 2023 Nov;55(11):1562-1572. doi: 10.1016/j.dld.2023.03.011. Epub 2023 Jun 10.
PMID: 37308396DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2020
First Posted
September 23, 2020
Study Start
April 25, 2016
Primary Completion
June 28, 2019
Study Completion
November 15, 2019
Last Updated
September 23, 2020
Record last verified: 2020-09