Fertility Preservation in Young Women With Cancer | NCT02878434

Studies
Fertility Preservation in Young Women With Cancer

NCT02878434

Sponsor

University Hospital, Gasthuisberg

Status

Recruiting

Last Update Posted

Nov 18, 2020Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Cancer
Fertility

Interventions

Not provided

Countries

Belgium
Netherlands

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2017Actual

Primary Completion Date

Jul 2032Estimated

Completion Date

Jul 2032Estimated

First Submitted Date

Aug 22, 2016

First Submission Date that Met QC Criteria

Aug 22, 2016

First Posted Date

Aug 25, 2016Estimated

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 17, 2020

Last Update Posted Date

Nov 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Frederic Amant, MD PhD, University Hospital, GasthuisbergPrincipal Investigator

Lead Sponsor

University Hospital, GasthuisbergOTHER

Collaborators

Name	Class
NKI-AvL	UNKNOWN
Medical University of Vienna	OTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	OTHER
Oslo University Hospital

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 researchers aim to record the incidence, treatment and long term follow up of fertility preserving cancer treatment. Both the oncological and fertility outcome are recorded.

Study population: All patients with a cancer for whom a fertility preserving cancer treatment is applied. The results of the study population are compared to young women undergoing standard cancer treatment.

Detailed Description

Cancer is the second leading cause of death during the reproductive years. The long term survival improves for most cancers, reaching 80% for pediatric cancer and more than 70% for cancers in adults between 20 and 49 years of age. Early detection and improvements in cancer treatment contribute to these figures. As a result, quality of life of which preservation of fertility is one aspect, becomes more important. Fertility may however be influenced by surgery and by the gonadotoxic effects of chemo and/or radiotherapy. Therefore, fertility sparing treatments are offered to young patients in order to maintain the wish to conceive after cancer treatment. This however is associated with deviation of standard treatment and many different strategies are applied among different centers. In addition, there is a lack of studies investigating the oncological safety of these fertility sparing treatment protocols. The results of this study will enable us to better inform clinicians and patients on the efficacy of fertility sparing cancer treatment.

Objective:

To record the incidence, treatment and long term follow up of fertility preserving cancer treatment. Both the oncological and fertility outcome are recorded.

Study design: International multicentre prospective observational trial

Main study parameters/endpoints:

Registration of cancer diagnosis, treatment and outcome. Both the oncologic and fertility outcome is registered.

All patients receive fertility sparing cancer treatment on their specific request.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fertility Outcome	pregnancy rate	10 years

Secondary Outcomes

Measure	Description	Time Frame
Oncological Outcome	Recurrence of cancer	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Young women who want to preserve their fertility during cancer treatment. Patients need to give their signed and written informed consent to participate in the study.

Exclusion Criteria:

Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

All women diagnosed with cancer for whom a fertility preserving cancer treatment is applied will be considered for inclusion.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Katrien Van Tornout	Contact	+3216342876		katrien.vantornout@uzleuven.be

Overall Officials

Name	Affiliation	Role
Frédéric Amant, MD, PhD	UZ Gasthuisberg & KU Leuven, Belgium	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Gasthuisberg, Katholieke Universiteit Leuven	Recruiting	Leuven		3000	Belgium

References Module

Citations

Not provided

Label	Type	Description	Intervention Names
Study group
control group

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 22, 2018	Mar 28, 2019	Prot_000.pdf
ICF	No	No	Yes	Informed Consent Form: adult	Oct 2, 2018	Mar 28, 2019	ICF_001.pdf
ICF	No	No	Yes	Informed Consent Form: child -18y	Oct 2, 2018	Mar 28, 2019	ICF_002.pdf
ICF	No	No	Yes	Informed Consent Form: parent for child -18y	Oct 2, 2018	May 22, 2019	ICF_003.pdf