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Gonadal Toxicity in Women With Hodgkin Lymphoma (FertHD)

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ClinicalTrials.gov Identifier: NCT01008735
Recruitment Status : Unknown
Verified November 2009 by Gruppo Italiano Studio Linfomi.
Recruitment status was:  Recruiting
First Posted : November 6, 2009
Last Update Posted : November 13, 2009
Sponsor:
Information provided by:

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
Hodgkin Lymphoma

Study Design

Study Type : Observational
Estimated 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 : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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. [ Time Frame: 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 [ Time Frame: from end of treatment until date of last contact/visit ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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:

Contacts and Locations

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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): NCT01008735


Contacts
Contact: Antonella Montanini, BSc, PhD +39 059 4223284 amontanini@unimore.it\

Locations
Italy
Gruppo Italiano Studio Linfomi Recruiting
Modena, Italy
Contact: Antonella Montanini, BSc, PhD    +39 059 4223284    amontanini@unimore.it   
Principal Investigator: Massimo Federico, MD         
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
More Information

Responsible Party: Massimo Federico, Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier: NCT01008735     History of Changes
Other Study ID Numbers: FertHD
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: November 13, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases