Clinical trial NCT04374175: SERum-bank for PANcreatic Cancer
Official title: SERum-bank for PANcreatic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adenocarcinoma
Keywords: Adenocarcinoma
Pancreatic cancer
Adiponectin
Blood sample
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There are 2 groups: patients with adenocarcinoma (ADENOCARCINOMA GROUP) and without (CONTROL GROUP)

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum adiponectin concentration
timeFrame: Months : 0
Secondary outcomes:
measure: Serum CA19.9 concentration
timeFrame: Months : 0, 3, 6, 9, 12
measure: Tumor response and progression rates according to RECIST v1.1
timeFrame: Month 12
measure: Progression-free survival
timeFrame: Months : 24
measure: Overall survival
timeFrame: Months : 24
measure: Serum adiponectin concentration
timeFrame: Months : 3, 6, 9, 12
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: Institut Cancérologique Lucien Newirth (ICLN)
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Nicolas WILLIET, MD
role: PRINCIPAL_INVESTIGATOR
References: