Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT01993498

Chronic Toxicities Related to Treatment in Patients With Localized Cancer

Led by UNICANCER · Updated on 2024-10-18

14750

Participants Needed

1

Research Sites

1149 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Chronic Toxicities Related to Treatment in Patients With Localized Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women
  • Aged 18 years and over
  • Diagnosed with invasive breast cancer by cytology or histology
  • No clinical evidence of metastasis at the time of inclusion
  • Untreated for breast cancer including surgery not yet performed
  • Receiving social security coverage
  • Able to understand and communicate in French
  • Provided free and informed consent for biological samples, questionnaires, and resource usage data
  • Since February 2022, either under 45 years old at diagnosis, or have CT2-3, cN0-3, HER2+ (HR+ or HR-), or HR-HER2-
  • Or eligible for Pembrolizumab, Olaparib, TDM1, Abemaciclib, or Ribociclib
Not Eligible

You will not qualify if you...

  • Metastatic breast cancer
  • Local recurrence of breast cancer
  • History of cancer within 5 years before study entry except basal cell skin cancer or carcinoma in situ of the cervix
  • Already received treatment for breast cancer
  • Blood transfusion within the last 6 months
  • Persons deprived of liberty or under legal supervision (including guardianship)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Gustave roussy

Villejuif, France, 94805

Actively Recruiting

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Research Team

C

Catherine Gaudin

CONTACT

A

Anne Laure Martin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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