NCT00429455

Brief Summary

Primary Objective: \- To understand the importance of receiving information on fertility- and menopause-related treatment effects for female patients undergoing hematopoietic stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

2.4 years

First QC Date

January 29, 2007

Last Update Submit

July 31, 2012

Conditions

Stem Cell Transplantation

Keywords

FertilityMenopauseHematopoietic Stem Cell TransplantationQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

  • Number of Survey Responders

    2 Years

Study Arms (1)

Survey Participants

Female patients who had a hematopoietic stem cell transplantation between January 1987 and September 2004 at M. D. Anderson Cancer Center.

Behavioral: Survey

Interventions

SurveyBEHAVIORAL

3-Part Questionnaire

Survey Participants

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Female patients who had a hematopoietic stem cell transplantation between January 1987 and September 2004 at M. D. Anderson Cancer Center.

You may qualify if:

  • Female patients who had a hematopoietic stem cell transplantation between January 1987 and September 2004 at M. D. Anderson Cancer Center.
  • Age 16 to 50 years at the time of the transplant.

You may not qualify if:

  • History of ovarian cancer.
  • History of hysterectomy/oophorectomy
  • Non-English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Naoto Ueno, MD, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 31, 2007

Study Start

March 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)