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Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer (KSF2)

C

Centre Oscar Lambret

Status

Active, not recruiting

Conditions

Breast Cancer

Treatments

Procedure: Pelvic Ultrasound
Biological: Biological Test
Procedure: Consultation

Study type

Interventional

Funder types

Other

Identifiers

NCT03795246
KSF2-1707

Details and patient eligibility

About

Interventional research with low risks and constraints, prospective and monocentric on the assessment of long-term fertility in patients who underwent an adjuvant sequential chemotherapy with or without a controled ovarian hyperstimulation. This study follows a previous one called NCT 01614704.

Full description

The patients will have a follow-up once a year during ten years beginning at the end of their chemotherapy.

They will have a consultation in oncology consisting of:

  • a clinical exam,
  • a collection and follow-up of oncological data
  • a collection of ongoing cancer treatments

and a consultation in gynecology consisting of:

  • a pelvic ultrasound scan (for AFC: Antral Follicle Count)
  • a biological test (FSH, LH, E2, AMH)
  • a collection of gynecological data, contraception and reproductive medicine

Enrollment

132 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients included in the study CT 01614704
  • Informed and written consent
  • Affiliated to the National Social Security System

Exclusion criteria

  • Impossibility to submit at the study procedures due to geographic, social or mental reasons
  • Patient deprived of their liberty or under guardianship or tutorship.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

132 participants in 1 patient group

Study Process
Experimental group
Description:
Consultation, Biological Test, Pelvic Ultrasound
Treatment:
Procedure: Consultation
Biological: Biological Test
Procedure: Pelvic Ultrasound

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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