NCT01993498 Chronic Toxicities Related to Treatment in Patients With Localized Cancer
| NCT ID | NCT01993498 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNICANCER |
| Condition | Breast Cancer Nos Metastatic Recurrent |
| Study Type | INTERVENTIONAL |
| Enrollment | 14,750 participants |
| Start Date | 2012-02-20 |
| Primary Completion | 2034-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 14,750 participants in total. It began in 2012-02-20 with a primary completion date of 2034-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 : 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…)
Eligibility Criteria
CANTO - Breast Inclusion Criteria: * Women, * 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 : 1. Age \< 45 years at diagnostic 2. Or CT2-3, cN0-3, HER2+(RH+or RH-) or RH-HER2- 3. 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).
Contact & Investigator
Inès VAZ-LUIS, Professor
STUDY DIRECTOR
Gustave Roussy - Villejuif
Frequently Asked Questions
Who can join the NCT01993498 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Nos Metastatic Recurrent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01993498 currently recruiting?
Yes, NCT01993498 is actively recruiting participants. Contact the research team at c-gaudin@unicancer.fr for enrollment information.
Where is the NCT01993498 trial being conducted?
This trial is being conducted at Villejuif, France.
Who is sponsoring the NCT01993498 clinical trial?
NCT01993498 is sponsored by UNICANCER. The principal investigator is Inès VAZ-LUIS, Professor at Gustave Roussy - Villejuif. The trial plans to enroll 14,750 participants.
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