A Prospective Cohort to Investigate Survivorship Issues in Patients With Early Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- UNICANCER
- Enrollment
- 14,750
- Locations
- 2
- Primary Endpoint
- Evaluation of chronic toxicity in patients treated for non-metastatic breast cancer
Study Overview
Brief 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 :
- 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 ...)
- To describe incidence, clinical presentation, and outcome of chronic toxicities.
- To describe the psychological, the social and the economic impacts of chronic toxicities.
- 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...)
Detailed Description
SPECIFIC AIM I: TO DEVELOP A TOXICITY DATABASE ON A COHORT OF 20,000 WOMEN WITH STAGE I-III (NON METASTATIC) BREAST CANCER
Selection criteria The cohort will include female patients with non-metastatic breast cancer (stage I-III) without any selection based on their characteristics (except stage) or treatment. They may be included in other concomitant clinical studies.
Patients will have to sign informed consent and will have to benefit from social security.
The lack of selection criteria is related to the fact that the cohort aims at investigating toxicity in the whole population of breast cancer from a public health perspective.
Sample size The cohort plans to include 14750 women in 13 years. A cohort of 14750 patients will allow to detect a two fold increased in the risk of a specific toxicity in a homogenous subgroup.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 years and over,
- •With an invasive breast cancer diagnosed by cytology or histology,
- •No clinical evidence of metastasis at the time of inclusion,
- •Untreated including scored for breast cancer surgery in progress,
- •Patient receiving a social security system,
- •Patient mastering the French language,
- •Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage.
- •(Since february 2022) Patient :
- •Age < 45 years at diagnostic
- •Or CT2-3, cN0-3, HER2+(RH+or RH-) or RH-HER2-
- •Or Eligible to Pembrozilumab, Olaparib, TDM1, Abemaciclib or Ribociclib
Exclusion Criteria
- •Metastatic breast cancer,
- •Local recurrence of breast cancer,
- •History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix,
- •Already received treatment for breast cancer ongoing,
- •Blood transfusion performed for less than six months,
- •Persons deprived of liberty or under supervision (including guardianship).
- •CANTO - Lung
- •Inclusion Criteria:
- •Aged 18 years and over, Having lung cancer diagnosed by cytology or histology or suspected cancer of the lung,
- •Tumor cTX to cT4, cN0-3,
- •No clinical evidence of metastasis at the time of inclusion (patients with metastases on extension assessment within 6 months following diagnosis will be removed from the study),
- •Eligible for curative treatment by surgery or radiotherapy * (note patients treated with exclusive chemotherapy, exclusive radiotherapy or exclusive stereotactic radiotherapy will be out of study)
- •Lack of treatment received for current lung cancer, including surgical treatment
- •Patient benefiting from a social protection scheme,
- •Patient mastering the French language,
- •Free and informed consent for additional biological samples, the different questionnaires and the collection of information on resource consumption.
- •Exclusion Criteria:
- •Metastatic lung cancer,
- •Local relapse of lung cancer,
- •History of cancer within 3 years prior to study entry other than basal cell cutaneous or epithelioma in situ of the cervix,
- •Treatment already received for current lung cancer,
- •Blood transfusion carried out less than 6 months ago,
- •Persons deprived of liberty or under guardianship (including curatorship).
Outcomes
Primary Outcomes
Evaluation of chronic toxicity in patients treated for non-metastatic breast cancer
Time Frame: 8 years
Secondary Outcomes
No secondary outcomes reported