Gonadal Toxicity in Women With Hodgkin Lymphoma (FertHD)

November 11, 2009 updated by: Gruppo Italiano Studio Linfomi

Observational Retrospective Study to Evaluate the Incidence of the Gonadal Toxicity in Women of Reproductive Age With Hodgkin Lymphoma

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy
        • Recruiting
        • Gruppo Italiano Studio Linfomi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients with Hodgkin lymphoma diagnosed until 2007 in Italy will be considered eligible for this study. Cases will be identified from the archives of GISL.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
women with hodgkin lymphoma treated with chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of gonadal toxicity in terms of irreversible amenorrhea and infertility, in women of reproductive age with Hodgkin lymphoma treated with chemotherapy.
Time Frame: from end of treatment until date of last contact/visit
from end of treatment until date of last contact/visit

Secondary Outcome Measures

Outcome Measure
Time Frame
role of a prophylactic treatment with oral contraceptives and GnRH analogs in preventing gonadal damage
Time Frame: from end of treatment until date of last contact/visit
from end of treatment until date of last contact/visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Studio Linfomi

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Study Registration Dates

First Submitted

November 3, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (Estimate)

November 6, 2009

Study Record Updates

Last Update Posted (Estimate)

November 13, 2009

Last Update Submitted That Met QC Criteria

November 11, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FertHD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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