SERPAN: SERum-bank for PANcreatic Cancer
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Biological: Blood sample
Blood sample will be performed
|
| Control group Patient with no adenocarcinoma will be included. They will have blood sample at the inclusion visit. |
Biological: Blood sample
Blood sample will be performed
|
Outcome Measures
Primary Outcome Measures
- Serum adiponectin concentration [Months : 0]
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%.
Secondary Outcome Measures
- Serum CA19.9 concentration [Months : 0, 3, 6, 9, 12]
Measure by blood sample result Threshold for Comparison of diagnostic performance compared to serum adiponectin concentration
- Tumor response and progression rates according to RECIST v1.1 [Month 12]
Tumor response and progression rates defined according to RECIST v1.1 criteria according to a serum threshold of the prognostic biomarker to be identified by logistic regression analyzes.
- Progression-free survival [Months : 24]
- Overall survival [Months : 24]
- Serum adiponectin concentration [Months : 3, 6, 9, 12]
Measure by blood sample result Serum adiponectin concentration to correlate with cancer progression or not.
Eligibility Criteria
Criteria
ADENOCARCINOMA GROUP
Inclusion Criteria:
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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.
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At the start of treatment (before surgery / 1st course of chemotherapy)
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Age ≥ 18 years
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Patient affiliated or entitled to a social security system
Exclusion Criteria:
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Patient refusal
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Acute renal failure
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Child-Pugh B or C cirrhosis
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Patient under guardianship or curators
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Other synchronous cancer or history of cancer <5 years
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Language barrier
CONTROL GROUP
Inclusion Criteria:
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Age ≥ 40 years
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Patient affiliated or entitled to a social security system
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Digestive endoscopy for any reason other than cancer or chronic inflammatory bowel disease
Exclusion Criteria:
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Patient refusal
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Acute renal failure
-
Child-Pugh B or C cirrhosis
-
Patient under guardianship or curators
-
Other synchronous cancer or history of cancer <5 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut Cancérologique Lucien Newirth (ICLN) | Saint-Priest-en-Jarez | France | 42270 | |
| 2 | CHU Saint-Etienne | Saint-Étienne | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Saint Etienne
Investigators
- Principal Investigator: Nicolas WILLIET, MD, CHU Saint-Etienne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20CH035
- 2020-A00393-36