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Chronic Toxicities Related to Treatment in Patients With Localized Cancer

NCT01993498 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14750

Last updated 2024-10-18

No results posted yet for this study

Summary

The aims of the cohort will be to quantify impact of cancer treatments toxicities , and to generate predictors of chronic toxicity in patients with non-metastatic cancer. Study of the original cohort will be focused on localized breast cancer patients, other localisation in non-metastatic setting will be explored furtherwise, fist of all in lung cancer.

The project will include four specific aims :

1. To develop a database of chronic treatment related toxicity in a cohort of 14750 women with stage I-III breast cancer (= non metastatic), whatever these treatments are (surgery; radiation therapy; chemotherapy …)
2. To describe incidence, clinical presentation, and outcome of chronic toxicities.
3. To describe the psychological, the social and the economic impacts of chronic toxicities.
4. To generate predictors for chronic toxicities in order to prevent them, based upon biological criteria.

The expected impact of these toxicities, when identified, will be to improve quality of life and to decrease health cost, by the early identification of patients at high risk of toxicity. Such early identification could lead to prevent toxic effect by: a. developing prevention strategies, b. substituting toxic treatment by a non (less) toxic one.

Also, such cohort will offer a quantification of the impact of treatment toxicity, that could be further used to quantify medical usefulness of strategies that aim at decreasing treatment toxicities (implementation of predictive biomarker for resistance, cytotoxic-free regimen etc…)

Conditions

  • Breast Cancer Nos Metastatic Recurrent
  • Early Lung Cancer

Interventions

PROCEDURE

blood sampling

blood samples collection

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Inès VAZ-LUIS, Professor · Gustave Roussy - Villejuif

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-20
Primary Completion
2034-03-31
Completion
2034-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01993498 on ClinicalTrials.gov