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FertHD: Gonadal Toxicity in Women With Hodgkin Lymphoma

Sponsor
Gruppo Italiano Studio Linfomi (Other)
Overall Status
Unknown status
CT.gov ID
NCT01008735
Collaborator
(none)
150
Enrollment
1
Location

Study Details

Study Description

Brief Summary

The Gruppo Italiano Studio Linfomi has been collecting data on patients with Hodgkin Lymphoma (HL) since 1988. This archive represents a homogeneous series of consecutive patients with HL. The very long follow up and the availability of clinical and treatment data make it feasible to perform a study on the gonadal toxicity related to treatment for HL.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Observational Retrospective Study to Evaluate the Incidence of the Gonadal Toxicity in Women of Reproductive Age With Hodgkin Lymphoma
    Study Start Date :
    Jul 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    women with hodgkin lymphoma treated with chemotherapy

    Outcome Measures

    Primary Outcome Measures

    1. incidence of gonadal toxicity in terms of irreversible amenorrhea and infertility, in women of reproductive age with Hodgkin lymphoma treated with chemotherapy. [from end of treatment until date of last contact/visit]

    Secondary Outcome Measures

    1. role of a prophylactic treatment with oral contraceptives and GnRH analogs in preventing gonadal damage [from end of treatment until date of last contact/visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female patients in complete remission after chemotherapy for Hodgkin lymphoma

    • Age ≥ 18 e < 40 years

    • Previous regular menstrual cycle

    • No previous or concomitant gynecological diseases affecting reproducing function

    • No other chemo-radiotherapy for other neoplasm

    • Written informed consent

    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gruppo Italiano Studio Linfomi Modena Italy

    Sponsors and Collaborators

    • Gruppo Italiano Studio Linfomi

    Investigators

    • Study Chair: Francesco Angrilli, MD, GISL
    • Study Chair: Simona Falorio, MD, GISL
    • Study Chair: Massimo Federico, MD, GISL

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01008735
    Other Study ID Numbers:
    • FertHD
    First Posted:
    Nov 6, 2009
    Last Update Posted:
    Nov 13, 2009
    Last Verified:
    Nov 1, 2009
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease

    Study Results

    No Results Posted as of Nov 13, 2009