NCT01008735

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
Last Updated

November 13, 2009

Status Verified

November 1, 2009

First QC Date

November 3, 2009

Last Update Submit

November 11, 2009

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (1)

women with hodgkin lymphoma treated with chemotherapy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gruppo Italiano Studio Linfomi

Modena, Italy

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Francesco Angrilli, MD

    GISL

    STUDY CHAIR

  • Simona Falorio, MD

    GISL

    STUDY CHAIR

  • Massimo Federico, MD

    GISL

    STUDY CHAIR

Central Study Contacts

Antonella Montanini, BSc, PhD

CONTACT

+39 059 4223284amontanini@unimore.it\

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2009

First Posted

November 6, 2009

Study Start

July 1, 2009

Last Updated

November 13, 2009

Record last verified: 2009-11

Locations

IT(1)