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

NCT03193671 | Completed DMC

• 1 other identifier: Ksundfeldt
• Study Type: observational
• Target: 684
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Neoplasms; Diagnoses Disease; Biomarkers; Algorithms

Keywords

HE4; CA125; RMI; ROMA

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (1)

• Improve triage of patients to tertiary centers for surgery

  12 months

Study Arms (4)

Benign

Benign tumors, pre-and postmenopausal

Diagnostic Test: Diagnosis

Malignant

Malignant tumors, pre-and postmenopausal

Diagnostic Test: Diagnosis

Borderline

Borderline tumors, pre-and postmenopausal

Diagnostic Test: Diagnosis

Malignant+borderline

Malignant+borderline tumors, pre-and postmenopausal

Diagnostic Test: Diagnosis

Interventions

Diagnosis DIAGNOSTIC_TEST

Improving diagnosis

Benign; Borderline; Malignant; Malignant+borderline

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Based on gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with a cyst/tumor in the pelvis already enrolled for surgery. Included at 6 different Hospitals.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Gothenburg University, Sahlgrenska University Hospital

Gothenburg, Gothenburg, 41345, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34388324 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: September 1, 2013
• Primary Completion: February 29, 2016
• Study Completion: February 29, 2016
• Last Updated: August 29, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)