Examining TLR4+ Blood Cells in Patients with Solid Cancer
Characterisation of TLR4+ Blood Cells in Patients With Solid Cancer
This study is testing how certain immune cells in the blood can be activated to improve immunotherapy for patients with solid cancers who are just starting treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 4 sites (Bron and 3 other locations) |
| Trial ID | NCT06131775 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of TLR4+ blood cells in patients diagnosed with various types of solid cancers. It aims to understand how these immune cells can be activated to enhance the effectiveness of immunotherapy, particularly in patients who have not previously received immune checkpoint inhibitors. Participants will undergo blood sampling to analyze the characteristics and behavior of these cells in relation to their cancer treatment. The study includes patients with both metastatic and resectable tumors, focusing on those who are initiating immunotherapy.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a histologically confirmed diagnosis of solid tumors who are either starting immunotherapy or are eligible for surgery.
Not a fit: Patients with secondary malignancies or those who have received prior anticancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved immunotherapy strategies for patients with solid tumors, potentially increasing their treatment options and outcomes.
How similar studies have performed: While the approach of examining TLR4+ cells in cancer patients is relatively novel, previous studies have shown promise in utilizing immune system activation for cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient older than 18 years * Patient who gave its written informed consent to participate to the study * Patient with histologically confirmed diagnosis of any type of malignancy (solid tumors) * Patient with a minimum of 6 months life expectation at inclusion * Patient covered by a medical insurance Inclusion criteria specific to cohort 1: \- Patient with metastatic disease or unresectable locally advanced malignancy (solid tumors) who is naive of immune checkpoint inhibitors (ICI)-based immunotherapy and is due to initiate an ICI immunotherapy alone or in combination with any other systemic anticancer treatment. Inclusion criteria specific to cohort 2: \- Patient with a diagnosed malignancy amenable to surgery with curative intent who is naive of any anticancer treatment Exclusion Criteria: * Patient with secondary malignancy unless this malignancy is cured with no evidence of recurrence for at least 5 years. * Pregnant or breastfeeding woman or expecting to conceive * Patient who is deprived of liberty due to judicial or administrative decision * Patient with known psychiatric disorders that would interfere with cooperation with the requirements of the trial * Patient admitted in a social or sanitary institution for an objective other than the one of this trial * Adult patient under legal protection
Where this trial is running
Bron and 3 other locations
- Pneumology Unit — Bron, France (Recruiting)
- Dermatology Unit — Pierre-Bénite, France (Recruiting)
- Oncological and Gynecological Surgery Unit, — Pierre-Bénite, France (Recruiting)
- Oncology Unit, Hospices Civils de Lyon Sud — Pierre-Bénite, France (Recruiting)
Study contacts
- Study coordinator: Charles DUMONTET, MD
- Email: charles.dumontet@chu-lyon.fr
- Phone: 06 82 13 66 14
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.