Clinical trialObsRecruiting
SERum-bank for PANcreatic Cancer
- Outcome
- Ongoing
- Phase
- Obs
- Status
- Recruiting
- Study type
- Observational
- Start
- 1 April 2020
- Expected end
- 1 January 2026
- Enrollment
- 400 participants
- Sites
- 2
- Primary outcomes
- Serum adiponectin concentration
- Sponsor
- Other
- Results posted
- No
- Last update
- 18 March 2025
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Brief summary public domain (ClinicalTrials.gov)
This study is about pancreatic cancer. If the diagnostic cancer is done at an early stage (\<2cm), the chances of recovery are very good. But the main problem is there is not any detections means for this cancer. Sadly, when there is a cancer diagnostic , it's already too late in the majority of cases, because the cancer is in an advanced case. Today, there is no any effective means of detection... Blood markers can be a simple means of early detection
Detailed description public domain (ClinicalTrials.gov)
The purpose of this study is to establish a sero-library in a case-control cohort to assess several potentially useful serum biomarkers, such as adiponectin in the early diagnosis of pancreatic cancer.
Intervention public domain (ClinicalTrials.gov)
Biological: Blood sample. Blood sample will be performed
Arm public domain (ClinicalTrials.gov)
Adenocarcinoma group (): Patients with Adenocarcinoma will be included. They will have blood sample at the inclusion visit and at 3 months, 6 months, 9 months and 12 months after.
Arm public domain (ClinicalTrials.gov)
Control group (): Patient with no adenocarcinoma will be included. They will have blood sample at the inclusion visit.
Primary outcome public domain (ClinicalTrials.gov)
Serum adiponectin concentration. Measure by blood sample result Serum adiponectin concentration threshold for which the specificity will be 100% for the diagnosis of pancreatic cancer with a sensitivity of 80%. Time frame: Months : 0.
Secondary outcome public domain (ClinicalTrials.gov)
Serum CA19.9 concentration. Time frame: Months : 0, 3, 6, 9, 12.
Secondary outcome public domain (ClinicalTrials.gov)
Tumor response and progression rates according to RECIST v1.1. Time frame: Month 12.
Secondary outcome public domain (ClinicalTrials.gov)
Progression-free survival. Time frame: Months : 24.
Secondary outcome public domain (ClinicalTrials.gov)
Overall survival. Time frame: Months : 24.
Secondary outcome public domain (ClinicalTrials.gov)
Serum adiponectin concentration. Time frame: Months : 3, 6, 9, 12.
Eligibility public domain (ClinicalTrials.gov)
ADENOCARCINOMA GROUP Inclusion Criteria: * Documented adenocarcinoma (cytology / anatomopathology), all stages, except if the tumor is immediately resectable and does not require preoperative cytological evidence. In this case, the inclusion and the first collection of the sero bank is done preoperatively. The diagnostic confirmation will therefore be made post-operatively at the risk of being excluded in the event of a different diagnosis. * At the start of treatment (before surgery / 1st course of chemotherapy) * Age ≥ 18 years * Patient affiliated or entitled to a social security system Exclusion Criteria: * Patient refusal * Acute renal failure * Child-Pugh B or C cirrhosis * Patient under guardianship or curators * Other synchronous cancer or history of cancer \<5 years * Language barrier CONTROL GROUP Inclusion Criteria: * Age ≥ 40 years * Patient affiliated or entitled to a social security system * Digestive endoscopy for any reason other than cancer or chronic inflammatory bowel disease Exclusion Criteria: * Patient refusal * Acute renal failure * Child-Pugh B or C cirrhosis * Patient under guardianship or curators * Other synchronous cancer or history of cancer \<5 years
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 400 participants (estimated).