AdenocarcinomaSERPANNCT04374175
SERum-bank for PANcreatic Cancer
An observational study of Adenocarcinoma, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma
- What is being tested?
- Blood sample
- How many people
- 400 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Apr 2020to 1 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There are 2 groups: patients with adenocarcinoma (ADENOCARCINOMA GROUP) and without (CONTROL GROUP)
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 12Show fewer
- CONTROL GROUP
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU Saint-Etienne
Saint-Etienne
Nicolas WILLIET, MD
Jean-Marc PHELIP, MD PhD
- Recruiting
Institut Cancérologique Lucien Newirth (ICLN)
Saint-Priest-en-Jarez, 42270
Lea SABAN-ROCHE, MD
About this study
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
Read the 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.
- Conditions
- Adenocarcinoma
- Being tested
- Blood sample
- Keywords
- Adenocarcinoma, Pancreatic cancer, Adiponectin, Blood sample
- Medical subject headings
- Adenocarcinoma, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Blood sample will be performed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Blood sample | |
| Control group | Patient with no adenocarcinoma will be included. They will have blood sample at the inclusion visit. Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Months : 0
Secondary outcomes (5)
Serum CA19.9 concentration
Measure by blood sample result Threshold for Comparison of diagnostic performance compared to serum adiponectin concentration
Measured: Months : 0, 3, 6, 9, 12
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.
Measured: Month 12
Progression-free survival
Measured: Months : 24
Overall survival
Measured: Months : 24
Serum adiponectin concentration
Measure by blood sample result Serum adiponectin concentration to correlate with cancer progression or not.
Measured: Months : 3, 6, 9, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Apr 2020
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas WILLIET, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374175
- Sponsor's protocol ID
- 20CH035
- Other IDs
- 2020-A00393-36
- Acronym
- SERPAN
- Status last verified
- Mar 2025
- First submitted
- 28 Apr 2020
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SERum-bank for PANcreatic Cancer
- ClinicalTrials.gov ID
- NCT04374175
- Acronym / sponsor ID
- SERPAN / 20CH035
- Conditions
- Adenocarcinoma
- Keywords
- Adenocarcinoma, Pancreatic cancer, Adiponectin, Blood sample
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenocarcinoma group | – | Biological: Blood samplePatients 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. |
| Control group | – | Biological: Blood samplePatient with no adenocarcinoma will be included. They will have blood sample at the inclusion visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are 2 groups: patients with adenocarcinoma (ADENOCARCINOMA GROUP) and without (CONTROL GROUP)
Key inclusion criteria (7 listed)
- 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
- Age ≥ 40 years
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood sample will be performed | Biological | Adenocarcinoma group, Control group |
Primary outcome
Serum adiponectin concentration
Time frame: 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%.
5 secondary outcomes
Serum CA19.9 concentration
Time frame: Months : 0, 3, 6, 9, 12
Tumor response and progression rates according to RECIST v1.1
Time frame: Month 12
Progression-free survival
Time frame: Months : 24
Overall survival
Time frame: Months : 24
Serum adiponectin concentration
Time frame: Months : 3, 6, 9, 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas WILLIET, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas WILLIET, MD ((0)477829029 ext. +33, nicolas.williet@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum adiponectin concentration (time frame: Months : 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.