Gonadal Toxicity in Women With Hodgkin Lymphoma

Hodgkin Lymphoma Clinical Trial

— FertHD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01008735
• Other study ID #: FertHD
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2009
• Last updated: November 11, 2009
• Start date: July 2009

Study information

• Verified date: November 2009
• Source: Gruppo Italiano Studio Linfomi
• Contact: Antonella Montanini, BSc, PhD
• Phone: +39 059 4223284
• Email: amontanini[@]unimore.it\
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Locations

Country	Name	City	State
Italy	Gruppo Italiano Studio Linfomi	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Studio Linfomi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No