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Gonadal Toxicity in Women With Hodgkin Lymphoma (FertHD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Gruppo Italiano Studio Linfomi.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier:
NCT01008735
First received: November 3, 2009
Last updated: November 11, 2009
Last verified: November 2009
History of Changes
  Purpose

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
Hodgkin Lymphoma

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gruppo Italiano Studio Linfomi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2009
Groups/Cohorts
women with hodgkin lymphoma treated with chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Massimo Federico, Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier: NCT01008735     History of Changes
Other Study ID Numbers: FertHD
Study First Received: November 3, 2009
Last Updated: November 11, 2009
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013