Prognostic Value of Divpenia and CD4 Count in Relapsed Breast or Lung Cancer Patients (LYMPHOS1)
This study is currently recruiting participants.
Verified December 2012 by Centre Leon Berard
Sponsor:
Centre Leon Berard
Collaborators:
UBET (Biostatistic and Therapeutic Evaluation Unit)
BEC (Department of Clinical Sciences)
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01306188
First received: February 28, 2011
Last updated: December 11, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Lung Cancer |
Biological: Breast cancer cohort Biological: Lung cancer cohort |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Study of Prognostic Value of T Cell Receptor Diversity and CD4 Lymphopenia in First Relapse Breast or Lung Cancer Patients |
Resource links provided by NLM:
Further study details as provided by Centre Leon Berard:
Primary Outcome Measures:
- Analyse the prognostic value of divpenia [ Time Frame: 3 month (lung cancer) 6 month (breast cancer) ] [ Designated as safety issue: No ]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).
Secondary Outcome Measures:
- Analyse prognostic value of clinico-biological parameters (PS ECOG, LDH levels, - To establish that the divpenia factor is independent of clinical and biological prognostic factors (PS, LDH, metastasis localization, Hb, PMN, age, sex) [ Time Frame: 3 month (lung cancer) - 6 month (breast cancer) ] [ Designated as safety issue: No ]Establish that the divpenia factor is independent of clinical and biological prognostic factors (PS, LDH, initial metastasis localization, Hb, PMN, age, sex) to predict a early death,
- Prognostic score NDL [ Time Frame: 3 month (lung cancer) - 6 month (breast cancer) ] [ Designated as safety issue: No ]Establish that the prognostic score NDL which will combine in a two-dimensional graph the CD4 count or total lymphocytes count and TCR repertoire diversity will allow a better stratification of lympho-divpenic patients who will benefit from more appropriate treatments
- Characterization of other circulating markers [ Time Frame: 3 month (lung cancer) - 6 month (breast cancer) ] [ Designated as safety issue: No ]Characterize other circulating markers this could improve the identification of the early death risk (phenotypic markers, cytokines ...) in combination with the previous settings
Biospecimen Retention: Samples With DNA
Whole blood, plasma, PBMC
| Estimated Enrollment: | 180 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Breast cancer
Metastatic breast cancer
|
Biological: Breast cancer cohort
Blood samples must be made within 48 hours after the inclusion of the patient. Patients are treated according to the standards of the centre where they are supported. No follow-up is provided in this study. For each patient, the following analyses is performed:
|
|
Lung cancer
Metastatic lung cancer
|
Biological: Lung cancer cohort
Blood samples must be made within 48 hours after the inclusion of the patient. Patients are treated according to the standards of the centre where they are supported. No follow-up is provided in this study. For each patient, the following analyses is performed:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
2 cohorts of patients (breast and lung cancer), with locally advanced or metastatic cancer
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306188
Contacts
| Contact: David PEROL, MD | +33 4 78 78 27 52 | david.perol@lyon.unicancer.fr |
| Contact: Séverine GUILLEMAUT | +33 4 78 78 29 68 | severine.guillemaut@lyon.unicancer.fr |
Locations
| France | |
| Centre Léon Bérard | Recruiting |
| Lyon, France, 69008 | |
| Contact: Olivier TREDAN, MD olivier.tredan@lyon.unicancer.fr | |
| Principal Investigator: Olivier TREDAN, MD | |
| Sub-Investigator: Thomas BACHELOT, MD | |
| Sub-Investigator: Pierre BIRON, MD | |
| Sub-Investigator: Jean Yves BLAY, MD | |
| Sub-Investigator: Jérôme FAYETTE, MD | |
| Sub-Investigator: Jean Pierre GUASTALLA, MD | |
| Sub-Investigator: Sana LABIDI, MD | |
| Sub-Investigator: Isabelle RAY COQUARD, MD | |
| Sub-Investigator: Paul REBATTU, MD | |
| Sub-Investigator: Maurice PEROL, MD | |
| Sub-Investigator: Line CLAUDE, MD | |
| Hopital de la Croix Rousse | Recruiting |
| Lyon, France, 69004 | |
| Contact: Dominique ARPIN, MD dominique.arpin@chu-lyon.fr | |
| Principal Investigator: Dominique ARPIN, MD | |
| Hopital Privé Jean Mermoz | Active, not recruiting |
| Lyon, France, 69008 | |
| CHLS | Recruiting |
| Pierre Bénite, France, 69495 | |
| Contact: Pierre Jean SOUQUET, MD | |
| Principal Investigator: Pierre Jean SOUQUET, MD | |
Sponsors and Collaborators
Centre Leon Berard
UBET (Biostatistic and Therapeutic Evaluation Unit)
BEC (Department of Clinical Sciences)
Investigators
| Principal Investigator: | Olivier TREDAN, MD | Centre Léon Bérard |
More Information
Publications:
| Responsible Party: | Centre Leon Berard |
| ClinicalTrials.gov Identifier: | NCT01306188 History of Changes |
| Other Study ID Numbers: | LYMPHOS1 |
| Study First Received: | February 28, 2011 |
| Last Updated: | December 11, 2012 |
| Health Authority: | France : Centre Léon Bérard (CREC) |
Keywords provided by Centre Leon Berard:
|
metastatic cancer lymphopenia T cell receptor diversity |
Additional relevant MeSH terms:
|
Breast Neoplasms Lung Neoplasms Lymphopenia Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Respiratory Tract Neoplasms |
Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Leukopenia Leukocyte Disorders Hematologic Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013