Ovarian NeoplasmsNCT03193671
Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis
An observational study of Ovarian Neoplasms and Diagnoses Disease, run by Göteborg University at 1 site in Sweden.
Trial summary
This study evaluates the biomarkers CA125 and HE4 and the algorithms RMI and ROMA on a normal population in the western region of Sweden. The aim is to improve diagnosis of ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Diagnoses Disease, Biomarkers
- What is being tested?
- Diagnosis
- How many people
- 684 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2013to 29 Feb 2016
- How long will I take part?
- 12 Weeks
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with a cyst/tumor in the pelvis already enrolled for surgery. Included at 6 different Hospitals.
Who may be able to join
- 18 years of age, understand spoken and written Swedish information, admitted for surgery for a cyst/tumos in the pelvis
Who cannot join
- Rejected participation, cytotoxic chemotherapy prior to surgery, rejected surgery, serum sample failure, already included at another hospital
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Gothenburg University, Sahlgrenska University Hospital
Gothenburg, Gothenburg, 41345
About this study
This study evaluates the biomarkers CA125 and HE4 and the algorithms RMI and ROMA on a normal population in the western region of Sweden. The aim is to improve diagnosis of ovarian cancer.
If the investigators observe a clear improvement in the early diagnosis of EOC, the investigators aim to implement the best strategy for all patients with suspected pelvic tumor mass in the western region of Sweden.
Read the detailed description
The investigators are currently using CA125 and RMI in diagnosing patients with a pelvic cyst/tumor and referring them to tertiary centers for surgery in the western region of Sweden. The diagnostic accuracy is unsatisfying why the investigators are evaluating HE4 and ROMA as a complement, in combination or separately to improve diagnostic accuracy.
The trial is based on a normal population cohort of patients included at all the hospitals in the region. The patients were included before surgery and the biomarkers analysed on serum samples withdrawn preoperatively.
If the investigators observe a clear improvement in the early diagnosis of EOC, the investigators aim to implement the best strategy for all patients with suspected pelvic tumor mass in the western region of Sweden.
- Conditions
- Ovarian Neoplasms, Diagnoses Disease, Biomarkers, Algorithms
- Being tested
- Diagnosis
- Keywords
- HE4, CA125, RMI, ROMA
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosisDiagnostic test
Improving diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Benign | Benign tumors, pre-and postmenopausal Receives: Diagnostic Test: Diagnosis | |
| Malignant | Malignant tumors, pre-and postmenopausal Receives: Diagnostic Test: Diagnosis | |
| Borderline | Borderline tumors, pre-and postmenopausal Receives: Diagnostic Test: Diagnosis | |
| Malignant+borderline | Malignant+borderline tumors, pre-and postmenopausal Receives: Diagnostic Test: Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can the investigators improve diagnostic accuracy in women diagnosed with a cyst/tumor in the pelvis
Finding the true cases and avoiding unnecessary surgery, a descriptive analysis of a normalpopulation
Measured: 12 months
Secondary outcomes (1)
Improve triage of patients to tertiary centers for surgery
Referring the correct cases from a normal population.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Sep 2013
- Primary completion29 Feb 2016
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 684 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Sundfeldt, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193671
- Sponsor's protocol ID
- Ksundfeldt
- Status last verified
- Aug 2017
- First submitted
- 19 Jun 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD are coded with a unique number only available to the main researchers
Publications
Lycke M, Ulfenborg B, Malchau Lauesgaard J, Kristjansdottir B, Sundfeldt K. Consideration should be given to smoking, endometriosis, renal function (eGFR) and age when interpreting CA125 and HE4 in ovarian tumor diagnostics. Clin Chem Lab Med. 2021 Aug 13;59(12):1954-1962. doi: 10.1515/cclm-2021-0510. Print 2021 Nov 25.
PubMed 34388324
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis
- ClinicalTrials.gov ID
- NCT03193671
- Acronym / sponsor ID
- Ksundfeldt
- Conditions
- Ovarian Neoplasms, Diagnoses Disease, Biomarkers, Algorithms
- Keywords
- HE4, CA125, RMI, ROMA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 21 Jun 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.
This study evaluates the biomarkers CA125 and HE4 and the algorithms RMI and ROMA on a normal population in the western region of Sweden. The aim is to improve diagnosis of ovarian cancer.
If the investigators observe a clear improvement in the early diagnosis of EOC, the investigators aim to implement the best strategy for all patients with suspected pelvic tumor mass in the western region of Sweden.
Detailed description
The investigators are currently using CA125 and RMI in diagnosing patients with a pelvic cyst/tumor and referring them to tertiary centers for surgery in the western region of Sweden. The diagnostic accuracy is unsatisfying why the investigators are evaluating HE4 and ROMA as a complement, in combination or separately to improve diagnostic accuracy.
The trial is based on a normal population cohort of patients included at all the hospitals in the region. The patients were included before surgery and the biomarkers analysed on serum samples withdrawn preoperatively.
If the investigators observe a clear improvement in the early diagnosis of EOC, the investigators aim to implement the best strategy for all patients with suspected pelvic tumor mass in the western region of Sweden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Benign | – | Diagnostic Test: DiagnosisBenign tumors, pre-and postmenopausal |
| Malignant | – | Diagnostic Test: DiagnosisMalignant tumors, pre-and postmenopausal |
| Borderline | – | Diagnostic Test: DiagnosisBorderline tumors, pre-and postmenopausal |
| Malignant+borderline | – | Diagnostic Test: DiagnosisMalignant+borderline tumors, pre-and postmenopausal |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with a cyst/tumor in the pelvis already enrolled for surgery. Included at 6 different Hospitals.
Key inclusion criteria (1 listed)
- 18 years of age, understand spoken and written Swedish information, admitted for surgery for a cyst/tumos in the pelvis
Key exclusion criteria (1 listed)
- Rejected participation, cytotoxic chemotherapy prior to surgery, rejected surgery, serum sample failure, already included at another hospital
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 |
|---|---|---|
| DiagnosisImproving diagnosis | Diagnostic test | Benign, Borderline, Malignant, Malignant+borderline |
Primary outcome
Can the investigators improve diagnostic accuracy in women diagnosed with a cyst/tumor in the pelvis
Time frame: 12 months
Finding the true cases and avoiding unnecessary surgery, a descriptive analysis of a normalpopulation
1 secondary outcome
Improve triage of patients to tertiary centers for surgery
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Derived from this study: PubMed 34388324Lycke M, Ulfenborg B, Malchau Lauesgaard J, Kristjansdottir B, Sundfeldt K. Consideration should be given to smoking, endometriosis, renal function (eGFR) and age when interpreting CA125 and HE4 in ovarian tumor diagnostics. Clin Chem Lab Med. 2021 Aug 13;59(12):1954-1962. doi: 10.1515/cclm-2021-0510. Print 2021 Nov 25.
- Individual participant dataSharing planned: No. All IPD are coded with a unique number only available to the main researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neoplasms and Diagnoses Disease, run by Göteborg University at 1 site in Sweden.
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 1 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: finished, as of the sponsor's last update on 29 Aug 2017. 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 Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Can the investigators improve diagnostic accuracy in women diagnosed with a cyst/tumor in the pelvis (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03193671, which also lists 1 linked publication.
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 29 Aug 2017.