Examining the link between circulating tumor DNA and peritoneal carcinomatosis in patients receiving PIPAC treatment
Study Evaluating the Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Treated With PIPAC
NA · Institut de Cancérologie de Lorraine · NCT04766502
This study is testing how levels of tumor DNA in the blood change in patients with peritoneal carcinomatosis who are receiving a special treatment called PIPAC, while also looking at how this affects their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut de Cancérologie de Lorraine (other) |
| Locations | 1 site (Vandœuvre-lès-Nancy) |
| Trial ID | NCT04766502 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to analyze the changes in plasma circulating tumor DNA (ctDNA) levels in patients with peritoneal carcinomatosis undergoing three PIPAC sessions, spaced 6 to 8 weeks apart. Blood samples will be collected before and after each session to assess ctDNA concentration. Additionally, the study will evaluate the quality of life of participants using the EORTC QLQ-C30 survey, administered at various points throughout the treatment process. The overall duration of the study is set for 42 months.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with peritoneal carcinomatosis who are not eligible for cytoreduction surgery and have an indication for PIPAC.
Not a fit: Patients who may benefit from cytoreduction surgery or have contraindications to PIPAC will not receive benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of ctDNA dynamics and improve treatment strategies for patients with peritoneal carcinomatosis.
How similar studies have performed: While this approach is relatively novel, similar studies investigating ctDNA in cancer treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * WHO 0 to 2 * Patient with cancer in the form of peritoneal carcinosmatois not eligible for cytoreduction surgery * A histological diagnosis of the primary tumor or peritoneal carcinomatosis is essential. * Patient with an indication for PIPAC for any reason (whether as part of a clinical research protocol or not). Patients with prior treatment with PIPAC are eligible. * Patients with abdominal metastases or a single metastasis regardless of location (oligometastasis). * For patients of childbearing age need for an effective method of contraception * Informing patients and obtaining informed consent, dated and signed. * Patient affiliated with a social security scheme Exclusion Criteria: * Age \< 18 years old * WHO \> 3 * Patient who may benefit from cytoreduction surgery * Patient with a contraindication to PIPAC * Extra peritoneal disease with the exception of oligometastatic disease * Persons deprived of liberty or under guardianship (including curatorship) * Impossibility to undergo the medical follow-up of the trial for social, geographical or psychological reasons. * For patients of childbearing age without an effective method of contraception * Woman who is pregnant, likely to be pregnant, or breastfeeding
Where this trial is running
Vandœuvre-lès-Nancy
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France (RECRUITING)
Study contacts
- Principal investigator: Cécilia CERIBELLI, MD — Institut de Cancérologie de Lorraine
- Study coordinator: Jean Louis MERLIN, PU PH
- Email: jl.merlin@nancy.unicancer.fr
- Phone: 03 83 65 60 62
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.
Conditions: Peritoneal Carcinomatosis, PIPAC, Circulating tumour DNA, Quality of Life