Improved Early Diagnosis in Female Pelvic Cancer With OC Detect

NCT ID: NCT06613230

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 490 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-12-31

Brief Summary

The goal of this observational study is to learn if so called Volatile Organic Compounds (VOCs) in blood can be used for early diagnosis of ovarian cancer. The main question it aims to answer is:

Can OC Detect, a new in vitro diagnostic instrument, distinguish between VOC patterns in blood plasma from women with ovarian cancer (especially in early stage) and VOC patterns in helthy women? Participants are previosuly diagnosed patients with ovarian cancer, who agreed to store their blood samples in biobanks for future medical research purposes. Healthy female blood donors serve as benign control blood samples.

Detailed Description

Pelvic Endometrial and Ovarian cancer (ovarian-/tubal-/peritoneal cancer) is the sixth and seventh most frequent type of cancer and ovarian cancer the fourth leading cause of cancer related death among Swedish women. Endometrial cancer gives mostly early symptoms but two thirds of patients with ovarian cancer are diagnosed with advanced stage of the disease, and this is reflected in poor outcome. Early diagnosis is challenging especially in ovarian cancer.

Plasma protein biomarker panels with improved diagnostic performance and predicting survival in patients with ovarian tumors have been performed by several research groups. The sensitivity is good, but specificity is today not good enough for screening purposes. Several blood-based protein biomarker candidates for endometrial cancer detection have been reported but the protein biomarkers have so far only clinical relevance in advanced or recurrent endometrial cancers. However, there is a need for improved more specific broader biomarker panels for discrimination between localized or metastatic disease and preoperative risk stratification especially in endometrial cancer patients. Such improved biomarker panels would be able to predict metastatic disease and guide adjuvant chemotherapy treatment.

Endogenous volatile organic compounds (VOCs) are products of metabolic activity in the body and changes to these VOCs can be characteristic of specific disease processes such as cancer development. Analyses in plasma of VOCs such as triethylamine, pyridine, toluene, etc. with Field-Effect-Transistor (FET) -based gas sensors have shown to be able to measure VOCs very accurately in low concentrations (Bastuck thesis, 2009). The metabolism in cancer cells vastly differs from that of healthy cells. Elevated glycolysis leads to increases in lactate and fumarate metabolites resulting in altered VOC abundances in exhaled breath. Experimental data indicate that the detection of VOCs released by various cancer cells may be useful in early diagnoses of cancer. In patients with ovarian cancer, analyzes of specific VOC: s in blood has shown promising results to discriminate patient with ovarian cancer from healthy women (Horvath). The investigators have very recently in 37 patients out 38 with ovarian cancer found VOC indicating cancer which indicates a preliminary sensitivity of 97 %. In the total material of 68 analyzed samples, 3 false positive results were found which indicates a specificity of 90 %. In a population with 1 % malignancy the positive predictive value would be almost 10 % and negative predictive value 99.9 %.

In the current study, samples from more ovarian cancer patients will be included, and also samples from patients with other cancer types (totally 245 patients, of which 50 ovarian cancers). The aim will be to see if good sensitivity and specificity can be achived with larger patient population (same or better values than in the previous study). Special focus will be put on early stages of ovarian cancer, as well as borderline tumours. The investigators aim also to see how distinct is VOC pattern for ovarian cancer compared to the VOC patterns for the other cancer forms. Finally, the study will give preliminary answer if VOC patterns for the other types of cancer (i.e., breast, colorectal, bladder, endometrie, cervix, ...) is specific so it could be used in the future for development of dedicated diagnostic tools for those diseases.

Conditions

Ovarian Cancer; Endometrial Cancer; Breast Cancer; Lymphoma; Malignant Melanoma; Sarcoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cancer

Blood plasma samples from female patients with ovarian cancer of stage I-IV or borderline tumours, stored in biobanks in Sweden.

Also blood samples from female patients with other cancer types (endometrial, lymphoma, breast, malignant melanoma and sarcoma)

No interventions assigned to this group

Healthy blood donors

Healthy blood donors samples from women aged 18-70 years

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Blood plasma (1ml) from patients with ovarian cancer or borderline ovarian tumors, or other cancer tumors (endometrial, lymphoma, breast, malignant melanoma, sarcoma)
• Blood plasma (1 ml) from healthy volunteer controls
• Signed informed consent by cancer patients for use of biobank blood samples in research
• Signed informed consent by healthy blood donors for use in research

Exclusion Criteria

• < 18 years (both for cancer patients and healthy blood donors)
• Man (healthy blood donors)
• >70 years (healthy blood donors)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

VOC Diagnostics

INDUSTRY

Sponsor Role: collaborator

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Christer Borgfeldt

Professor in Obsterics and Gynaecology at Lund University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jens Eriksson, Ass Prof

Role: STUDY_DIRECTOR

Linkoeping University

Locations

Linkoping University

Linköping, , Sweden

Region Skane

Lund, , Sweden

Countries

Sweden

Other Identifiers

VOC-CLIN-001

Identifier Type: OTHER

Identifier Source: secondary_id

232100-0255

Identifier Type: -

Identifier Source: org_study_id