Evaluation of Attitudes About Fertility | NCT01705561

Studies
Evaluation of Attitudes About Fertility

NCT01705561

Sponsor

Grupo de Estudios Clínicos Oncológicos Peruano

Status

Unknown status

Last Update Posted

Oct 15, 2012Estimated

Enrollment

450Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Peru

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 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Not provided

Completion Date

Jun 2013Estimated

First Submitted Date

Oct 10, 2012

First Submission Date that Met QC Criteria

Oct 11, 2012

First Posted Date

Oct 12, 2012Estimated

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 12, 2012

Last Update Posted Date

Oct 15, 2012Estimated

Name	Class
European Organisation for Research and Treatment of Cancer - EORTC	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Assess the attitudes and feelings of premenopausal Latin American women towards the risk of loss their fertility by adjuvant chemotherapy.
Correlate the attitudes with other variables including age at diagnosis, already having children, number of children, level of instruction, marital status, frequency of menstrual cycle.

Detailed Description

Eligibility criteria:

Latin American women with evidence of cancer diagnosis at premenopausal status
Over 18 years
Agree to sign the informed consent
No evidence of infertility.

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

450Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women with breast cancer diagnosis in premenopausal
over 18 years
signed informed consent

Exclusion Criteria:

Evidence of infertility at diagnosis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

women with diagnosis of breast cancer in pre menopausal status

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
HENRY L GOMEZ, DR	Grupo de Estudios Clínicos Oncológicos Peruano	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Enfermedades Neoplasicas		Lima	Lima Province	34	Peru

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided