Evaluating a blood test to predict treatment response in patients with intestinal neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter, open-label study aims to assess the Inflammation Based Index (IBI) score as a predictive marker for clinical and radiological responses in patients with inoperable or metastatic, progressive grade 1 or 2 intestinal neuroendocrine tumors treated with Lu-177 oxodotreotide. The IBI score is calculated based on C-reactive protein and albumin levels, categorizing patients into low, intermediate, or high mortality risk. The study will involve additional blood tests and data collection to evaluate the effectiveness of the IBI score in predicting treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient aged ≥ 18 years.
2. Patient with histologically confirmed grade 1 or 2 neuroendocrine tumor of the midgut, inoperable or metastatic.
3. Patient eligible for Lu-177 oxodotreotide therapy in accordance with its marketing authorization.
4. Evidence of progression in the 12 months preceding Lu-177oxodotreotide therapy, confirmed by imaging techniques commonly used in current practice (thoraco-abdomino-pelvic CT and/or liver MRI, Ga-68 DOTA somatostatin analog PET-CT) +/- liver involvement greater than 50%.
5. Disease measurable according to RECIST 1.1 criteria in thoraco-abdomino-pelvic CT +/- liver MRI.
6. Patient affiliated to a social security scheme in France.
7. Patient having signed informed consent prior to study inclusion and prior to any specific study procedure.

Exclusion Criteria:

1. Previous treatment with Lu-177 oxodotreotide.
2. Any contraindication to treatment with Lu-177 oxodotreotide.
3. Morbid obesity (BMI \> 40).
4. Uncontrolled/unbalanced active inflammatory disease in the 3 months prior to inclusion.
5. Active carcinoid heart disease or other acute cardiovascular event.
6. Active infection not treated within 15 days.
7. Pregnant or breast-feeding woman.
8. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol.
9. Patient deprived of liberty or under legal protection (guardianship, legal protection).

Where it's running

• CHU de Bordeaux
  Bordeaux, France Recruiting
• Centre François Baclesse
  Caen, France Recruiting
• CHU de Lille
  Lille, France Recruiting
• CHU de Lyon
  Lyon, France Recruiting
• Hôpital La Timone
  Marseille, France Recruiting
• Institut de Cancérologie de Montpellier
  Montpellier, France Recruiting

Study contacts

• Study coordinator: Lavinia VIJA
• Email: Vija.Lavinia@iuct-oncopole.fr
• Phone: 05 31 15 56 47

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Routine shallow-coverage Whole Genome Sequencing of Cervical Smears to See if Ovarian Cancer is Found Earlier

  Researchers test whether analyzing DNA from cervical smears with shallow whole-genome sequencing can help detect high-grade serous ovarian cancer early in patients undergoing treatment for this cancer.

  Recruiting Institut Claudius Regaud · Toulouse · NCT07821879

• Male Breast Cancer Predisposition Factor: Create a Control Group

  This study tests genetic and psychosocial data in men who are relatives of men with breast cancer but who themselves have no cancer history.

  Recruiting Institut Claudius Regaud · Toulouse · NCT07558343

• Biomarkers and immune responses in early-stage solid cancers treated with immunotherapy

  This study tests immune biomarkers in patients with early-stage solid cancers who are receiving immune checkpoint blockade before surgery.

  Recruiting Institut Claudius Regaud · Toulouse and 2 other locations · NCT07427186

• Atlas of cell organelles and protein patterns in breast cancer subtypes

  This project will collect tumor and blood samples from people with early or newly metastatic breast cancer to test how much fat accumulates in tiny cell structures (lipid droplets) and to map protein patterns across tumor subtypes.

  Recruiting Institut Claudius Regaud · Toulouse · NCT07233928

• Comparing blood levels of the free‑DXd payload from trastuzumab‑deruxtecan by BMI in people with advanced or metastatic breast cancer

  This study will test whether body mass index changes blood levels of the free‑DXd payload in adults with locally advanced or metastatic HER2‑low or HER2‑positive breast cancer who are receiving trastuzumab‑deruxtecan.

  Recruiting at 6 sites Phase 4 Institut Claudius Regaud · Angers and 9 other locations · NCT07195344

• Detecting double-positive (tumor marker/CD45+) cells in the blood of people with metastatic cancer

  This one-day study will test two blood-based methods to find double-positive tumor/CD45+ circulating cells in adults who are about to start treatment for various metastatic cancers.

  Recruiting Institut Claudius Regaud · Toulouse · NCT06967961

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.