Impact of echo-endoscopy biopsy on circulating tumor cells in pancreatic cancer
Impact of Echo-endoscopy Biopsy on the Circulating Tumor Cell Level in the Portal System in Pancreatic Adenocarcinoma Management Care
This study is testing how a special type of biopsy for pancreatic cancer affects the number of tumor cells in the blood of patients suspected to have the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Institut Paoli-Calmettes Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT04677244 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how echo-endoscopic procedures affect the levels of circulating tumor cells (CTCs) in patients suspected of having pancreatic cancer. It will involve 42 patients who will undergo an echo-endoscopic biopsy and/or biliary drainage, with blood samples taken from the portal vein before and after the procedure. The study will analyze the quantity and characteristics of CTCs to assess the impact of the biopsy on tumor cell levels. Follow-up evaluations will occur every six months to monitor disease progression and patient health.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 40-85 suspected of having pancreatic cancer and scheduled for an echo-endoscopic biopsy.
Not a fit: Patients with visible carcinosis, ascites, or those unable to consent or follow the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of pancreatic cancer by providing insights into the effectiveness of echo-endoscopic procedures.
How similar studies have performed: While the specific approach of this study may be novel, similar studies assessing circulating tumor cells have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women aged 40-85 years old; * BMI\< 30 kg/m2; * Patients suspected of having pancreatic cancer for whom an ultrasound endoscopic biopsy and/or biliary drainage is planned; * Affiliation to, or beneficiary of, a social security scheme. Exclusion Criteria: * Woman who is pregnant or likely to become pregnant (without effective contraception) or breastfeeding ; * Person in an emergency situation, person of full age subject to a legal protection measure, or unable to express consent; * Biliary drainage or attempt at prior biliary drainage outside the center ; * Preliminary oncological treatment for pancreatic pathology covered by the study; * Clinical and/or image-visible (CT/MRI) carcinosis ; * Ascites visible on imaging (CT/MRI) ; * Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons; * Contraindications to an endoscopic procedure.
Where this trial is running
Marseille
- Institut Paoli Calmettes — Marseille, France (Recruiting)
Study contacts
- Principal investigator: Fabrice CAILLOL, MD — Paoli Calmettes Institute
- Study coordinator: Dominique GENRE, MD
- Email: drci.up@ipc.unicancer.fr
- Phone: +33491223778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.