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Breast Cancer Toxicity (CANTO)

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ClinicalTrials.gov Identifier: NCT01993498
Recruitment Status : Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
UNICANCER

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 breast cancer.

The project will include four specific aims :

  1. To develop a database of chronic treatment related toxicity in a cohort of 20 000 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 over a maximum of 8 years.
  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…)


Condition or disease Intervention/treatment Phase
Breast Cancer Nos Metastatic Recurrent Procedure: blood sampling Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Cohort to Quantify and to Predict Treatment Related Chronic Toxicities in Patients With Non-metastatic Breast Cancer
Study Start Date : February 2012
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
breast cancer treatment + blood sampling
Standard treatment of breast cancer with intervention : samples collection
Procedure: blood sampling
blood samples collection




Primary Outcome Measures :
  1. Evaluation of chronic toxicity in patients treated for non-metastatic breast cancer [ Time Frame: 8 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women
  • Aged 18 years and over,
  • With an invasive breast cancer diagnosed by cytology or histology,
  • Tumors cT0 to cT3, CN0-3
  • 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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993498


Locations
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France
Gustave roussy
Villejuif, France, 94805
Sponsors and Collaborators
UNICANCER
Investigators
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Principal Investigator: Fabrice André Gustave Roussy - Villejuif

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01993498     History of Changes
Other Study ID Numbers: UC-0140/1103 CANTO
2011-A01095-36 ( Other Identifier: French Conpetant Authority )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
Access Criteria: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
Keywords provided by UNICANCER:
cancer toxicities
cohort
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases