Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker

NCT05763511 | Recruiting

• 1 other identifier: Ovarian cancer ctDNA
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This project investigates circulating tumor DNA (ctDNA) in patients with suspected ovarian malignancy. We hypothesize that measurement of ctDNA in women with suspected ovarian cancer can improve the diagnostic efficiency for preoperative differentiation between benign and malignant masses. Specifically, we hope to determine the diagnostic efficiency of ctDNA alone and ctDNA in combination with imaging modalities (ultrasonography, MRI, PET-CT) and CA 125 for preoperative differentiation between benign and malignant adnexal masses. Based on this, we hope to develop an improved diagnostic algorithm. The mutational profile and relation to tumour type, stage, treatment response and prognosis will be explored. Analyses of blood and tissue samples will be used to examine the disease development and biology. Blood samples, tumour tissue and data on imaging modalities as well as CA 125 will be collected prospectively in consecutive women referred to Aarhus University Hospital.

Conditions

Ovarian Neoplasms; Ovary Cancer; Ovarian Cysts

Outcome Measures

Primary Outcomes (1)

• Diagnostic efficiency (reference: histopathological diagnosis)

  Sensitivity, Specificity, Area under the receiver operation characteristic curve, positive and negative predictive values.

  6 months

Secondary Outcomes (5)

• Diagnostic efficiency of ctDNA combined with imaging (ultrasonography, MRI, PET-CT, CT, etc.) and CA 125 for differentiation of benign and malignant adnexal masses.

  6 months

• Disease stage

  6 months

• Treatment response

  2 years

• Survival

  5 years

• Tumour Biology

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred due to suspected ovarian cancer

You may qualify if:

• Suspected ovarian neoplasm
• Informed consent

You may not qualify if:

• Inability to give informed consent
• Previous ovarian cancer diagnosis

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Gynaecology and Obstetrics, Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and tumor tissue (after informed consent)

MeSH Terms

Conditions

Ovarian Neoplasms; Ovarian Cysts

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; Cysts

Study Officials

• Ina Marie Dueholm Hjorth, MD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ina Marie Dueholm Hjorth, MD

CONTACT

+4526192456; imhjorth@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, PhD student

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: March 10, 2023
• Study Start: July 1, 2022
• Primary Completion: December 4, 2024
• Study Completion (Estimated): May 4, 2029
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)