NCT02878434

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
75mo left

Started May 2017

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
May 2017Jul 2032

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

May 23, 2017

Completed
15.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2032

Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

15.1 years

First QC Date

August 22, 2016

Last Update Submit

November 17, 2020

Conditions

CancerFertility

Keywords

CancerFertilityPregnancyChemotherapyRadiotherapyLong termFollow up

Outcome Measures

Primary Outcomes (1)

  • Fertility Outcome

    pregnancy rate

    10 years

Secondary Outcomes (1)

  • Oncological Outcome

    5 years

Study Arms (2)

Study group

control group

Eligibility Criteria

Age0 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UZ Gasthuisberg, Katholieke Universiteit Leuven

Leuven, 3000, Belgium

RECRUITING

The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands

RECRUITING

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Frédéric Amant, MD, PhD

    UZ Gasthuisberg & KU Leuven, Belgium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrien Van Tornout

CONTACT

+3216342876katrien.vantornout@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

May 23, 2017

Primary Completion (Estimated)

July 1, 2032

Study Completion (Estimated)

July 1, 2032

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations

BE(1)NL(1)