Improved Early Diagnosis in Female Pelvic Cancer With OC Detect

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 70 Years
Gender	Female

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06613230
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Region Skane
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jens Eriksson, Ass Prof
Principal Investigator Affiliation	Linkoeping University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Sweden
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ovarian Cancer, Endometrial Cancer, Breast Cancer, Lymphoma, Malignant Melanoma, Sarcoma

Additional Details

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.

Arms & Interventions

Arms

: 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)

: Healthy blood donors

Healthy blood donors samples from women aged 18-70 years

Interventions

Contact a Trial Team

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International Sites

Linkoping University, Linkoping, Sweden

Status

Recruiting

Address

Linkoping University

Linkoping, ,

Site Contact

Jens Eriksson, Ass Prof

[email protected]

+46 70 839 31 22

Region Skane, Lund, Sweden

Status

Recruiting

Address

Region Skane

Lund, ,

Site Contact

Christer Borgfeldt, Prof

[email protected]

+46 70 995 04 72

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