Ovarian CancerNCT06613230
Improved Early Diagnosis in Female Pelvic Cancer With OC Detect
An observational study of Ovarian Cancer and Endometrial Cancer, run by Region Skane at 2 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer, Breast Cancer
- Type of treatment
- Injection or infusion
- How many people
- 490 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Feb 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Blood plasma samples from patients with ovarian and other types of cancer admitted to cancer clinics in south part of Sweden (Region Skane), who are diagnbosed with cancer and who have signed informed consent for storing of their blood samples in biobanks for future reseatrch purposes. The patients are psudo-anonymous. Healthy blood donors from Linköping University hospital who have signed informed consent allowing use of their blood in research after local approval. The helthy donors are anonymous.
Who may be able to join
- 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
Who cannot join
- < 18 years (both for cancer patients and healthy blood donors)
- Man (healthy blood donors)
- >70 years (healthy blood donors)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Improved Early Diagnosis and Survival in Female Pelvic Cancer (e.g. Ovarian Cancer) With OC Detect, (Pilot Study)
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.
Read the 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
- Keywords
- in vitro diagnostic, volatile organic compound, VOC, electronic nose, blood plasma samples, cancer diagnosis
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Breast Neoplasms, Lymphoma, Melanoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of VOC algorithm for ovarian cancer diagnosis
Classification of features of the VOC patterns in plasma of each ovarian cancer patient and each healthy control as cancer or healthy control, by OC Detect algorithm. Determination of false positives (FP)/ false negative (FN)/ true positive (TP)/ true negative (TN) diagnoses based on comparison to the ground truth clinical diagnoses from biobank and healthy controls. Determination of sensitivity, specificity and accuracy.
Measured: From time of blood sample collection for cancer diagnosis until the time of VOC measurement, assessed 1 year - 15 years post diagnosis
Secondary outcomes (2)
Performance of VOC algorithm for other patients with endometrial, breast, lymphoma, malignant melanoma and sarcoma patients.
Classification of features of the VOC patterns in plasma of each cancer patient and each healthy control as cancer or healthy control, by OC Detect algorithm. Determination of false positives (FP)/ false negative (FN)/ true positive (TP)/ true negative (TN) diagnoses based on comparison to the ground truth clinical diagnoses from biobank and healthy controls. Determination of sensitivity, specificity and accuracy for each cancer type.
Measured: From time of blood sample collection for cancer diagnosis until the time of VOC measurement, assessed 1 year - 15 years post diagnosis
Preliminary performance for an algorithm for all cancer types in the study, with special attention to ovarian cancer compared to the other cancer types
Classification of features for VOC patterns in plasma of all cancer types as specific other cancer type or as healthy control, after training of new algorithm for discrimination all cancer types in this study (multiple classification).
Measured: From time of blood sample collection for cancer diagnosis until the time of VOC measurement, assessed 1 year - 15 years post diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University, VOC Diagnostics
- Responsible party
- Principal investigator, Christer Borgfeldt, Region Skane
- Investigators
- Jens Eriksson, Ass Prof, Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613230
- Sponsor's protocol ID
- 232100-0255
- Other IDs
- VOC-CLIN-001
- Status last verified
- Apr 2025
- First submitted
- 26 Aug 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Early Diagnosis and Survival in Female Pelvic Cancer (e.g. Ovarian Cancer) With OC Detect, (Pilot Study)
- ClinicalTrials.gov ID
- NCT06613230
- Acronym / sponsor ID
- 232100-0255
- Conditions
- Ovarian Cancer, Endometrial Cancer, Breast Cancer, Lymphoma, Malignant Melanoma, Sarcoma
- Keywords
- in vitro diagnostic, volatile organic compound, VOC, electronic nose, blood plasma samples, cancer diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Linkoeping University, VOC Diagnostics
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Blood plasma samples from patients with ovarian and other types of cancer admitted to cancer clinics in south part of Sweden (Region Skane), who are diagnbosed with cancer and who have signed informed consent for storing of their blood samples in biobanks for future reseatrch purposes. The patients are psudo-anonymous. Healthy blood donors from Linköping University hospital who have signed informed consent allowing use of their blood in research after local approval. The helthy donors are anonymous.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- < 18 years (both for cancer patients and healthy blood donors)
- Man (healthy blood donors)
- >70 years (healthy blood donors)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance of VOC algorithm for ovarian cancer diagnosis
Time frame: From time of blood sample collection for cancer diagnosis until the time of VOC measurement, assessed 1 year - 15 years post diagnosis
Classification of features of the VOC patterns in plasma of each ovarian cancer patient and each healthy control as cancer or healthy control, by OC Detect algorithm. Determination of false positives (FP)/ false negative (FN)/ true positive (TP)/ true negative (TN) diagnoses based on comparison to the ground truth clinical diagnoses from biobank and healthy controls. Determination of sensitivity, specificity and accuracy.
2 secondary outcomes
Performance of VOC algorithm for other patients with endometrial, breast, lymphoma, malignant melanoma and sarcoma patients.
Time frame: From time of blood sample collection for cancer diagnosis until the time of VOC measurement, assessed 1 year - 15 years post diagnosis
Preliminary performance for an algorithm for all cancer types in the study, with special attention to ovarian cancer compared to the other cancer types
Time frame: From time of blood sample collection for cancer diagnosis until the time of VOC measurement, assessed 1 year - 15 years post diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Eriksson, Ass Prof study director
Linkoeping University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Endometrial Cancer, run by Region Skane at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of VOC algorithm for ovarian cancer diagnosis (time frame: From time of blood sample collection for cancer diagnosis until the time of VOC measurement, assessed 1 year - 15 years post diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.