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Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis

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ClinicalTrials.gov Identifier: NCT03193671
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Karin Sundfeldt, Göteborg University

Brief 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.

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.


Condition or disease Intervention/treatment
Ovarian Neoplasms Diagnoses Disease Biomarkers Algorithms Diagnostic Test: Diagnosis

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 The patients were included before surgery and the biomarkers analysed on serum samples withdrawn preoperatively.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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 684 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Weeks
Official Title: Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis
Actual Study Start Date : September 1, 2013
Actual Primary Completion Date : February 29, 2016
Actual Study Completion Date : February 29, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cysts

Group/Cohort Intervention/treatment
Benign
Benign tumors, pre-and postmenopausal
Diagnostic Test: Diagnosis
Improving diagnosis

Malignant
Malignant tumors, pre-and postmenopausal
Diagnostic Test: Diagnosis
Improving diagnosis

Borderline
Borderline tumors, pre-and postmenopausal
Diagnostic Test: Diagnosis
Improving diagnosis

Malignant+borderline
Malignant+borderline tumors, pre-and postmenopausal
Diagnostic Test: Diagnosis
Improving diagnosis




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Improve triage of patients to tertiary centers for surgery [ Time Frame: 12 months ]
    Referring the correct cases from a normal population.


Biospecimen Retention:   Samples With DNA
Serum samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Based on gender identity
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with a cyst/tumor in the pelvis already enrolled for surgery. Included at 6 different Hospitals.
Criteria

Inclusion Criteria:

  • 18 years of age, understand spoken and written Swedish information, admitted for surgery for a cyst/tumos in the pelvis

Exclusion Criteria:

  • Rejected participation, cytotoxic chemotherapy prior to surgery, rejected surgery, serum sample failure, already included at another hospital

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193671


Locations
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Sweden
Gothenburg University, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Göteborg University

Additional Information:

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Responsible Party: Karin Sundfeldt, Professor, Göteborg University
ClinicalTrials.gov Identifier: NCT03193671     History of Changes
Other Study ID Numbers: Ksundfeldt
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All IPD are coded with a unique number only available to the main researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karin Sundfeldt, Göteborg University:
HE4
CA125
RMI
ROMA

Additional relevant MeSH terms:
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Ovarian Neoplasms
Ovarian Cysts
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Cysts