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
Information provided by:
Gruppo Italiano Studio Linfomi
First received: November 3, 2009
Last updated: November 11, 2009
Last verified: November 2009
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.
||Observational Model: Cohort
Time Perspective: Retrospective
||Observational Retrospective Study to Evaluate the Incidence of the Gonadal Toxicity in Women of Reproductive Age With Hodgkin Lymphoma
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:
| Study Start Date:
women with hodgkin lymphoma treated with chemotherapy
|Ages Eligible for Study:
||18 Years to 40 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01008735
|Gruppo Italiano Studio Linfomi
|Modena, Italy |
|Contact: Antonella Montanini, BSc, PhD +39 059 4223284 firstname.lastname@example.org |
|Principal Investigator: Massimo Federico, MD |
Gruppo Italiano Studio Linfomi
||Francesco Angrilli, MD
||Simona Falorio, MD
||Massimo Federico, MD
No publications provided
||Massimo Federico, Gruppo Italiano Studio Linfomi
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 3, 2009
||November 11, 2009
||Italy: Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Neoplasms by Histologic Type
Immune System Diseases