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History of Changes for Study: NCT00525460
Young Women Diagnosed With Early Stage Ovarian Cancer: A Focus on Fertility Issues and Sexual Function
Latest version (submitted July 26, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 4, 2007 None (earliest Version on record)
2 December 19, 2007 Study Design, Study Status, Eligibility, Outcome Measures, Groups and Interventions and Sponsor/Collaborators
3 January 6, 2009 Study Status
4 October 30, 2009 Study Status
5 November 30, 2009 Recruitment Status, Study Status and Contacts/Locations
6 August 23, 2013 Sponsor/Collaborators and Study Status
7 February 19, 2014 Study Status
8 October 3, 2015 Recruitment Status, Study Status and Study Design
9 November 17, 2016 Study Status
10 July 26, 2018 Study Status
Comparison Format:

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Study NCT00525460
Submitted Date:  September 4, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: 05-382
Brief Title: Young Women Diagnosed With Early Stage Ovarian Cancer: A Focus on Fertility Issues and Sexual Function
Official Title: A Pilot Study of Young Women Diagnosed With Early Stage Ovarian Cancer: A Focus on Fertility Issues and Sexual Function
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2007
Overall Status: Recruiting
Study Start: April 2006
Primary Completion:
Study Completion:
First Submitted: September 4, 2007
First Submitted that
Met QC Criteria:
September 4, 2007
First Posted: September 5, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 4, 2007
Last Update Posted: September 5, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Dana-Farber Cancer Institute
Responsible Party:
Collaborators: Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is to ask youn women diagnosed with ovarian cancer who have undergone surgery that will allow them to have children in the future, on issues such as: education about their options to keep their ability to have children, after-chemotherapy treatment decision making, and reproductive history. The second purpose is to determine the effect of an early diagnosis of ovarian cancer on the sexual functioning of women.
Detailed Description:
  • Participants will be asked to complete a questionnaire either in the clinic or at home and return it to the research staff by mail or in person.
  • The study will involve being asked questions about the following: Fertility history; sexual history after being diagnosed with cancer; decision to have surgery that will allow them to have children; education they may or may not have received about the surgery that saved their ability to have children.
  • Answers to all questions will be kept confidential and participants will be identified by a number only.
Open or close this module Conditions
Conditions: Ovarian Cancer
Keywords: fertility
stage I ovarian cancer
stage II ovarian cancer
fertility sparing
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Health Services Research
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: N/A
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Intervention Details:
Behavioral: Fertility-Sparing Survey
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To survey young women diagnosed with ovarian cancer who have undergone fertility sparing surgery on issues such as fertility counseling, post treatment decision making and reproductive history.
Secondary Outcome Measures:
1. To determine the effect of an early diagnosis of ovarian cancer on the sexual functioning of women.
2. To determine the feasibility of the Fertility-Sparing Survey included in this study.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Women diagnosed with stage I or II invasive ovarian cancer, that underwent fertility sparing surgery
  • Women who were premenopausal prior to diagnosis
  • 40 years of age or younger at the time of ovarian cancer diagnosis
  • Completed therapy for early stage cancer
  • No evidence of recurrence
  • No history fo known infertility prior to diagnosis
  • No other significant medical conditions that would affect fertility
Open or close this module Contacts/Locations
Central Contact Person: Susana Campos, MD
Telephone: 617-632-5269
Email: scampos@partners.org
Central Contact Backup: Lauren Pereira
Telephone: 617-632-6617
Email: lpereira2@partners.org
Study Officials: Susana Campos, MD
Principal Investigator
Dana-Farber Cancer Institute
Locations: United States, Massachusetts
Massachusetts General Hospital
[Recruiting]
Boston, Massachusetts, United States, 02114
Contact:Principal Investigator: Richard Penson, MD
Beth Israel Deaconess Medical Center
[Recruiting]
Boston, Massachusetts, United States, 02115
Contact:Principal Investigator: Stephen Cannistra, MD
Dana-Farber Cancer Institute
[Recruiting]
Boston, Massachusetts, United States, 02115
Contact:Principal Investigator: Susana Campos, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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