An observational study in Cancer and Fertility, sponsored by University Hospital, Gasthuisberg. Recruiting at 2 sites in 2 countries. Open to female participants aged 0 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-11-18.
Sponsored by University Hospital, Gasthuisberg · Observational
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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.
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
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.
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.
10,822 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 200 across 2,641 observational studies indexed under Neoplasms.
Browse Neoplasms studies →University Hospital, Gasthuisberg is the lead sponsor of 51 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All women diagnosed with cancer for whom a fertility preserving cancer treatment is applied will be considered for inclusion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fertility Outcome
pregnancy rate
Time frame: 10 years
Oncological Outcome
Recurrence of cancer
Time frame: 5 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started May 2017 (actual). Primary completion is estimated for Jul 2032, 182 months after the start.
Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's planned 182 months is above that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University Hospital, Gasthuisberg