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Trial record 2 of 20 for:    cantos

Breast Cancer Toxicity (CANTO)

This study is currently recruiting participants.
Verified May 2015 by UNICANCER
Sponsor:
ClinicalTrials.gov Identifier:
NCT01993498
First Posted: November 25, 2013
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
UNICANCER
  Purpose

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 Intervention
Breast Cancer Nos Metastatic Recurrent Procedure: blood sampling

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Cohort to Quantify and to Predict Treatment Related Chronic Toxicities in Patients With Non-metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by UNICANCER:

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

Estimated Enrollment: 20000
Study Start Date: February 2012
Estimated Study Completion Date: March 2026
Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
breast cancer treatment + blood sampling
Standard treatment of breast cancer with intervention : samples collection
Procedure: blood sampling
blood samples collection

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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).
  Contacts and Locations
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


Contacts
Contact: christel Mesleard (0)1 44 23 55 51 ext + 33 c-mesleard@unicancer.fr
Contact: Anne Laure Martin (0)1 44 23 55 56 al-martin@unicancer.fr

Locations
France
Gustave roussy Recruiting
Villejuif, France, 94805
Contact: Fabrice ANDRE    (0)1 42 11 43 71 ext +33      
Principal Investigator: Laetitia Shanna RAJPAR         
Principal Investigator: Patrick SOULIE         
Principal Investigator: Severine GUIU         
Principal Investigator: Laurence VANLEMMENS         
Principal Investigator: Marion FOURNIER         
Principal Investigator: Anne LESUR         
Principal Investigator: Olivier TREDAN         
Principal Investigator: Paul henri COTTU         
Principal Investigator: Christelle LEVY         
Principal Investigator: Mario CAMPONE         
Principal Investigator: Carole TARPIN         
Principal Investigator: Florence LEREBOURS         
Principal Investigator: Hervé CURE         
Principal Investigator: Marie Ange MOURET REYNIER         
Principal Investigator: Olivier RIGAL         
Principal Investigator: Jean Marc FERRERO         
Principal Investigator: Thierry PETIT         
Principal Investigator: Pierre KERBRAT         
Principal Investigator: Antoine ARNAUD         
Sponsors and Collaborators
UNICANCER
Investigators
Principal Investigator: Fabrice André Gustave Roussy - Villejuif
  More Information

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 Submitted: October 17, 2013
First Posted: November 25, 2013
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by UNICANCER:
cancer toxicities
cohort
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases