Clinical Trial: Prognostic Value of Divpenia and CD4 Count in Relapsed Breast or Lung Cancer Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Study of Prognostic Value of T Cell Receptor Diversity and CD4 Lymphopenia in First Relapse Breast or Lung Cancer Patients

Brief Summary: 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.

Detailed Summary:

The therapeutic management recommendations of patients with metastatic cancer offer standard treatment in specific situations. But, there is always a subgroup of patients who do not benefit from treatment and which has a very low survival. The risk of death for patients is very variable depending on the initial cancer site, tumor aggressiveness and chemosensitivity of tumours.

It's therefore important to have relevant prognostic tools to predict such an excess of relative toxicity or drug resistance. Simple prognostic factors for survival as the performance status (PS) have already been highlighted in several studies. Thus, the possibility to identify a group of patients with a higher risk of mortality could be of major interest for clinicians. In fact such stratification will allow:

  • To limit this risk by adjusting the therapy and/or associated treatments (antibiotic prophylaxis, dose reduction ...),
  • To develop protocols for testing innovative strategies specific to this high risk population.

The objectives of these innovative protocols would be designed to correct lymphodivpenia.

The main objective is 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).

The secondary objectives are:

  • To establish that the divpenia factor is independent of clinical and biological prognostic factors (PS, LDH, haemoglobin, lymphopenia or ANC) to pr
    Sponsor: Centre Leon Berard

    Current Primary Outcome: Analyse the prognostic value of divpenia [ Time Frame: 3 month (lung cancer) 6 month (breast cancer) ]

    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).


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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) ]
      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) ]
      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) ]
      Characterize other circulating markers this could improve the identification of the early death risk (phenotypic markers, cytokines ...) in combination with the previous settings


    Original Secondary Outcome: Same as current

    Information By: Centre Leon Berard

    Dates:
    Date Received: February 28, 2011
    Date Started: July 2010
    Date Completion:
    Last Updated: July 1, 2015
    Last Verified: July 2015