Cancer in PregnancyABCIPNCT04904263
Advisory Board on Cancer, Infertility and Pregnancy
An observational study of Cancer in Pregnancy and Fertility Preservation, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cancer in Pregnancy, Fertility Preservation, Cancer
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 22 May 2021to 22 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older 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
Who may be able to join
- Pregnant women with a cancer diagnosis
- Women with a fertility related question after cancer diagnosis
- Postpartum cancer diagnosis
- Cancer treatment during pregnancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Gasthuisberg, Katholieke Universiteit Leuven
Leuven, 3000
Frederic Amant, MD, PhD, +31 16 342194, frederic.amant@uzleuven.be
Joosje Heimovaara, MD, joosje.heimovaara@uzleuven.be
About this study
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.
Read the 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.
- Conditions
- Cancer in Pregnancy, Fertility Preservation, Cancer, Pregnancy
- Keywords
- Cancer in Pregnancy, Fertility preservation
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start22 May 2021 (estimated)
- Primary completion22 May 2024 (estimated)
- Study completion22 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Collaborators
- Kom Op Tegen Kanker, European Research Council
- Responsible party
- Principal investigator, Frederic Amant, University Hospital, Gasthuisberg
- Investigators
- Frederic Amant, MD,PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904263
- Sponsor's protocol ID
- ABCIP
- Acronym
- ABCIP
- Status last verified
- May 2021
- First submitted
- 22 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advisory Board on Cancer, Infertility and Pregnancy
- ClinicalTrials.gov ID
- NCT04904263
- Acronym / sponsor ID
- ABCIP / ABCIP
- Conditions
- Cancer in Pregnancy, Fertility Preservation, Cancer, Pregnancy
- Keywords
- Cancer in Pregnancy, Fertility preservation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Collaborators
- Kom Op Tegen Kanker, European Research Council
- Study start
- 22 May 2021 (estimated)
- Primary completion
- 22 May 2024 (estimated)
- Study completion
- 22 May 2024 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (4 listed)
- Pregnant women with a cancer diagnosis
- Women with a fertility related question after cancer diagnosis
- Postpartum cancer diagnosis
- Cancer treatment during pregnancy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The impact of an international advisory board on cancer in pregnancy
Time frame: 1 year
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Link to the ABCIP platformLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic Amant, MD,PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer in Pregnancy and Fertility Preservation, run by University Hospital, Gasthuisberg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederic Amant, MD,PhD (+32 16 344252, frederic.amant@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of an international advisory board on cancer in pregnancy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.