Assessing Reproductive Outcomes in Young Female Cancer Su... | NCT01843140

Studies
Assessing Reproductive Outcomes in Young Female Cancer Survivors Through a National Fertility Preservation Registry

NCT01843140

Sponsor

University of California, San Diego

Status

Active, not recruiting

Last Update Posted

Oct 30, 2024Actual

Enrollment

55Actual

Phase

Not provided

Conditions

Cancer
Infertilty

Interventions

Not provided

Countries

United States

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

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011Actual

Primary Completion Date

Apr 1, 2028Estimated

Completion Date

Apr 1, 2028Estimated

First Submitted Date

Jul 26, 2012

First Submission Date that Met QC Criteria

Apr 25, 2013

First Posted Date

Apr 30, 2013Estimated

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

Oct 27, 2024

Last Update Posted Date

Oct 30, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hui-Chun Irene Su, Assistant Professor of Reproductive Medicine, University of California, San DiegoPrincipal Investigator

Lead Sponsor

University of California, San DiegoOTHER

Collaborators

Not provided

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 FIRST project is a national fertility preservation registry for young women facing cancer treatments. The investigators will examine how different cancers and treatments affect the reproductive health of young survivors. This prospective cohort study seeks to recruit young women close to time of cancer diagnosis and treatment. Participants will answer a yearly questionnaire on their current health. A subset of participants will provide dried blood spots to measure reproductive hormones. The primary goal of the study is to determine the risk of infertility and time to pregnancy in young female cancer survivors.

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

Retention

Enrollment

55Actual

Label	Type	Description	Intervention Names
Young female cancer survivors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Risk of infertility	Participants will be assessed for infertility on average each year from age 18 to 51, the age of natural menopause.	Annually up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
Time to pregnancy		Annually up to 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with cancer or exposure to cancer treatment
English speaking
Ability to consent to the study

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Young women ages 18-44 who have been diagnosed with cancer or exposed to cancer treatment

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSD Moores Cancer Center		La Jolla	California	92093	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26181090	Derived	Dominick SA, McLean MR, Whitcomb BW, Gorman JR, Mersereau JE, Bouknight JM, Su HI. Contraceptive Practices Among Female Cancer Survivors of Reproductive Age. Obstet Gynecol. 2015 Sep;126(3):498-507. doi: 10.1097/AOG.0000000000000963.

ID	Term
D009369	Neoplasms
D007246	Infertility

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases