Prognostic Value of Divpenia and CD4 Count in Relapsed Breast or Lung Cancer Patients (LYMPHOS1)

This study is ongoing, but not recruiting participants.
Sponsor:
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: January 30, 2014
Last verified: January 2014
  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 2014
Estimated Primary Completion Date: December 2014 (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:

  • The analysis of TCR and BCR repertoire diversity,
  • The phenotypic analysis of immune subpopulations,
  • The analysis of the global lymphopenia or subpopulations T,
  • The analyses by multiplex assay of a large panel of plasma cytokines and chemokines.
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:

  • The analysis of TCR and BCR repertoire diversity,
  • The phenotypic analysis of immune subpopulations,
  • The analysis of the global lymphopenia or subpopulations T,
  • The analyses by multiplex assay of a large panel of plasma cytokines and chemokines.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306188

Locations
France
Centre Léon Bérard
Lyon, France, 69008
Hopital de la Croix Rousse
Lyon, France, 69004
Hopital Privé Jean Mermoz
Lyon, France, 69008
CHLS
Pierre Bénite, France, 69495
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: January 30, 2014
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
Breast Diseases
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Skin Diseases
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014