Gonadal Toxicity in Women With Hodgkin Lymphoma | NCT01008735

Studies
Gonadal Toxicity in Women With Hodgkin Lymphoma

NCT01008735

Sponsor

Gruppo Italiano Studio Linfomi

Status

Unknown status

Last Update Posted

Nov 13, 2009Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Hodgkin Lymphoma

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 3, 2009

First Submission Date that Met QC Criteria

Nov 5, 2009

First Posted Date

Nov 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2009

Last Update Posted Date

Nov 13, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Label	Type	Description	Intervention Names
women with hodgkin lymphoma treated with chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antonella Montanini, BSc, PhD	Contact	+39 059 4223284		amontanini@unimore.it\

Overall Officials

Name	Affiliation	Role
Francesco Angrilli, MD	GISL	Study Chair
Simona Falorio, MD	GISL	Study Chair
Massimo Federico, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gruppo Italiano Studio Linfomi	Recruiting	Modena			Italy

Condition Browse Module

MeSH Terms

ID	Term
D006689	Hodgkin Disease

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided