Advisory Board on Cancer, Infertility and Pregnancy | NCT04904263

Studies
Advisory Board on Cancer, Infertility and Pregnancy

NCT04904263

Sponsor

University Hospital, Gasthuisberg

Status

Unknown status

Last Update Posted

May 27, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Cancer in Pregnancy
Fertility Preservation
Cancer
Pregnancy

Interventions

Not provided

Countries

Belgium

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

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2021Estimated

Primary Completion Date

May 22, 2024Estimated

Completion Date

May 22, 2024Estimated

First Submitted Date

May 22, 2021

First Submission Date that Met QC Criteria

May 22, 2021

First Posted Date

May 27, 2021Actual

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

May 22, 2021

Last Update Posted Date

May 27, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Frederic Amant, Prof. dr. Amant, University Hospital, GasthuisbergPrincipal Investigator

Lead Sponsor

University Hospital, GasthuisbergOTHER

Collaborators

Name	Class
Kom Op Tegen Kanker	OTHER
European Research Council	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 Advisory Board on Cancer, Infertility and Pregnancy provides a platform where physicians from all over the world can request recommendations regarding the medical care of pregnant women diagnosed with cancer or regarding fertility preservation. The platform will contain different national advisory boards, with their own coordinator and members, as well as an overarching international advisory board with an international coordinator and members from different national boards.

To investigate the impact of this platform, a year after its launch, data regarding the incoming requests will be extracted from the website, as well as all recommendation letters.

Detailed Description

The Advisory Board on Cancer, Infertility and Pregnancy (ABCIP)-platform will be a web-based platform where clinicians from all over the world can request advice from a group of experts on the field of Cancer and Pregnancy. The platform will contain different national advisory boards, with their own coordinator and members, as well as an overarching international advisory board with an international coordinator and members from different national boards.

Clinicians can fill in a format (attached) requesting for advice, using only pseudonymized patient data after agreeing a disclaimer:

All information filled in in the 'request advice' format needs to be regarded as anonymous or pseudonymous data. We recommend you to inform your patient and ask for approval when needed, based on the rules and regulations applicable in your country.

The filled out request will be sent to the specific national board of their own country, and if no national board is available, to the overarching international board.

. To investigate the impact of this platform, a year after its launch, data regarding the incoming requests will be extracted from the website, as well as all recommendation letters.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The impact of an international advisory board on cancer in pregnancy	To investigate the impact of this platform, a year after its launch, data regarding the incoming requests will be extracted from the website, as well as all recommendation letters. All requesting physicians will be asked to complete a survey including their experiences with the ABCIP, to what amount they followed the given recommendations and the outcomes of mother (and child)	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women with a cancer diagnosis
Women with a fertility related question after cancer diagnosis
Postpartum cancer diagnosis
Cancer treatment during pregnancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Advice can be requested regarding all patients with cancer during pregnancy, questions regarding patients with a fertility wish after cancer diagnosis or questions regarding patients with a postpartum cancer diagnosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Frederic Amant, MD,PhD	Contact	+32 16 344252		frederic.amant@uzleuven.be
Joosje Heimovaara, MD	Contact	+32 16 344252		joosje.heimovaara@uzleuven.be

Overall Officials

Name	Affiliation	Role
Frederic Amant, MD,PhD	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

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

Label	URL
Link to the ABCIP platform	View source

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided