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Recruiting NCT05116449

NCT05116449 Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care (IDSein)

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Clinical Trial Summary
NCT ID NCT05116449
Status Recruiting
Phase —
Sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche
Condition Breast Cancer Female
Study Type OBSERVATIONAL
Enrollment 310 participants
Start Date 2021-02-22
Primary Completion 2025-12-22

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Quality of life questionnaires

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 310 participants in total. It began in 2021-02-22 with a primary completion date of 2025-12-22.

⚠ 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 aim of this study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care.

Eligibility Criteria

Inclusion Criteria: * Woman with histologically confirmed invasive breast cancer for whom surgery is scheduled * Age\> 18 years old * Performance status ECOG \<2 * Patient speaking and understanding French and able to complete questionnaires * Patient affiliated or beneficiary of a social security scheme * Patient having read the information note and not objecting to the use of the data collected Exclusion Criteria: * male * Patient with metastatic breast cancer * Patient with bilateral breast cancer * History of cancer of less than 5 years * Active infection or other serious underlying condition that may prevent the patient from receiving treatment * History or progressive psychiatric illness * Person deprived of liberty or under guardianship * Inability to undergo medical monitoring for geographical, social or psychological reasons Indication of emergency amputation * Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * Pregnant, breastfeeding or parturient woman * Patient hospitalized without consent

Contact & Investigator

Central Contact

Jean-François Oudet

✉ jf.oudet@ecten.eu

📞 0683346567

Frequently Asked Questions

Who can join the NCT05116449 clinical trial?

This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05116449 currently recruiting?

Yes, NCT05116449 is actively recruiting participants. Contact the research team at jf.oudet@ecten.eu for enrollment information.

Where is the NCT05116449 trial being conducted?

This trial is being conducted at Guilherand-Granges, France, Le Havre, France.

Who is sponsoring the NCT05116449 clinical trial?

NCT05116449 is sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. The trial plans to enroll 310 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: November 2026  ·  Data Methodology