Ovarian CancerNCT03128294
Long Term Survivors in Ovarian Cancer
An observational study of Ovarian Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
In this study the investigators would like to explore the patient and tumour characteristics of long-term survivors of ovarian cancer (>10 years). Indentifiying the characteristics of long-term survivors not only helps find prognostic factors for survival but may aid in generating hypotheses for novel therapeutic… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Retrospective, cross-sectional descriptive analysis
- How many people
- 69 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2017to 31 Dec 2018
- 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: Long-term survivors of ovarian cancer (>10 years).
Who may be able to join
- To achieve a large enough study population of approximately 80 subjects, patients surviving >10 years after treatment for stage IIIC/IV epithelial ovarian cancer in the past 25 years will be included from five hospitals. Patients were diagnosed between 1979 and 2006 and treated in the north of the Netherlands. A list of subjects fitting these inclusion criteria will be extracted from the National Cancer Registry (NKR).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
In this study the investigators would like to explore the patient and tumour characteristics of long-term survivors of ovarian cancer (>10 years). Indentifiying the characteristics of long-term survivors not only helps find prognostic factors for survival but may aid in generating hypotheses for novel therapeutic strategies.
- Conditions
- Ovarian Cancer
- Being tested
- Retrospective, cross-sectional descriptive analysis
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective, cross-sectional descriptive analysisOther
This study is a retrospective, cross-sectional descriptive analysis, and concerns the extraction of data from anonymised patient files. A database will be constructed and descriptive statistics will be used to summarise the data.
| Study group | Role | What they receive |
|---|---|---|
| long-term survivors of ovarian cancer | long-term survivors of ovarian cancer Receives: Other: Retrospective, cross-sectional descriptive analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indentifiying the characteristics of long-term survivors
Indentifiying the characteristics of long-term survivors
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startJan 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: Data was not sufficiently complete and reliable for analysis (retrospective chart research)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A.K.L. Reyners, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128294
- Sponsor's protocol ID
- 201600799
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2017
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Survivors in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03128294
- Acronym / sponsor ID
- 201600799
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Data was not sufficiently complete and reliable for analysis (retrospective chart research)
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 25 Apr 2017 (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.
In this study the investigators would like to explore the patient and tumour characteristics of long-term survivors of ovarian cancer (>10 years). Indentifiying the characteristics of long-term survivors not only helps find prognostic factors for survival but may aid in generating hypotheses for novel therapeutic strategies.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| long-term survivors of ovarian cancer | – | Other: Retrospective, cross-sectional descriptive analysislong-term survivors of ovarian cancer |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Long-term survivors of ovarian cancer (>10 years).
Key inclusion criteria (1 listed)
- To achieve a large enough study population of approximately 80 subjects, patients surviving >10 years after treatment for stage IIIC/IV epithelial ovarian cancer in the past 25 years will be included from five hospitals. Patients were diagnosed between 1979 and 2006 and treated in the north of the Netherlands. A list of subjects fitting these inclusion criteria will be extracted from the National Cancer Registry (NKR).
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective, cross-sectional descriptive analysisThis study is a retrospective, cross-sectional descriptive analysis, and concerns the extraction of data from anonymised patient files. A database will be constructed and descriptive statistics will be used to summarise the data. | Other | long-term survivors of ovarian cancer |
Primary outcome
Indentifiying the characteristics of long-term survivors
Time frame: 2 years
Indentifiying the characteristics of long-term survivors
Results and safety
The study was stopped early (reason given: Data was not sufficiently complete and reliable for analysis (retrospective chart research)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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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.
A.K.L. Reyners, MD, PhD principal investigator
University Medical Center Groningen
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 Ovarian Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
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 1 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: stopped early, as of the sponsor's last update on 19 Apr 2024. 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 Netherlands. 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?
The study was stopped early (reason given: Data was not sufficiently complete and reliable for analysis (retrospective chart research)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indentifiying the characteristics of long-term survivors (time frame: 2 years). 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 19 Apr 2024.