Clinical trial · Observational
Prognostic Value of Divpenia and CD4 Count in Relapsed Breast or Lung Cancer Patients
Study of Prognostic Value of T Cell Receptor Diversity and CD4 Lymphopenia in First Relapse Breast or Lung Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The T and B cells repertoire diversity represent one of the immune defence level which controls the integrity of the organism and determines its ability to recognize and control infectious attacks and development of tumours. The study of the lymphocytes TCR and BCR diversity could permit to better understand how lymphopenia act on overall survival and to improve detection of high risk patients who could benefit of adapted therapies for better care.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast cancer cohort | Biological | — | UNRESOLVED |
| Lung cancer cohort | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Breast cancer
- description
- Metastatic breast cancer
- interventionNames
- Biological: Breast cancer cohort
- label
- Lung cancer
- description
- Metastatic lung cancer
- interventionNames
- Biological: Lung cancer cohort
Primary outcomes (1)
- measure
- Analyse the prognostic value of divpenia
- timeFrame
- 3 month (lung cancer) 6 month (breast cancer)
- description
- To show that T divpenia (low TCR combinatorial diversity \<30%) is a risk factor for early death after chemotherapy (early death: any death occurring within 3 months (lung cancer) or within 6 months (breast cancer) after the start of chemotherapy).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old, * Patients with an histologically proven, inoperable breast or lung tumour, * Metastatic disease before the start of any chemotherapy, * Signed written informed consent form, * Covered by a medical insurance, * Patient accepting the conservation of biological samples, * Locally advanced incurable disease (only breast tumour). Exclusion Criteria: * Hematological tumour, * Auto-immune disease (including HIV-positive - AIDS stage) or patients with immunosuppressive therapy, * Metastatic disease that had progressed after a first line chemotherapy, * Pregnant or lactating female or female of child-bearing potential not employing adequate contraception, * Patient deprived of liberty by a judicial or administrative, * Adult protected by law.
References
Publications (2)
- RESULTBelbaraka R, Tredan O, Ray-Coquard I, Chvetzoff G, Bajard A, Perol D, Ismaili N, Ismaili M, Errihani H, Bachelot T, Rebattu P. Factors of interrupting chemotherapy in patients with Advanced Non-Small-Cell Lung Cancer. BMC Res Notes. 2010 Jun 10;3:164. doi: 10.1186/1756-0500-3-164. PMID 20537187
- RESULTRay-Coquard I, Cropet C, Van Glabbeke M, Sebban C, Le Cesne A, Judson I, Tredan O, Verweij J, Biron P, Labidi I, Guastalla JP, Bachelot T, Perol D, Chabaud S, Hogendoorn PC, Cassier P, Dufresne A, Blay JY; European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Lymphopenia as a prognostic factor for overall survival in advanced carcinomas, sarcomas, and lymphomas. Cancer Res. 2009 Jul 1;69(13):5383-91. doi: 10.1158/0008-5472.CAN-08-3845. Epub 2009 Jun 23. PMID 19549917