Health TrialsbyHealthPanel

SERum-bank for PANcreatic Cancer

ConditionAdenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient refusal

Acute renal failure

Child-Pugh B or C cirrhosis

Patient under guardianship or curators

Trial population

There are 2 groups: patients with adenocarcinoma (ADENOCARCINOMA GROUP) and without (CONTROL GROUP)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample

    Biological/Vaccine

    Blood sample will be performed

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Adenocarcinoma group1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

Serum CA19.9 concentration

Measure by blood sample result Threshold for Comparison of diagnostic performance compared to serum adiponectin concentration

Time frame
Months : 0, 3, 6, 9, 12
2

Tumor response and progression rates according to RECIST v1.1

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.

Time frame
Month 12
3

Progression-free survival

Time frame
Months : 24
4

Overall survival

Time frame
Months : 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

Source ClinicalTrials.gov
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