Clinical trial · Observational
Improved Early Diagnosis in Female Pelvic Cancer With OC Detect
Improved Early Diagnosis and Survival in Female Pelvic Cancer (e.g. Ovarian Cancer) With OC Detect, (Pilot Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cancer
- description
- 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)
- label
- Healthy blood donors
- description
- Healthy blood donors samples from women aged 18-70 years
Primary outcomes (1)
- measure
- Performance of VOC algorithm for ovarian cancer diagnosis
- timeFrame
- From time of blood sample collection for cancer diagnosis until the time of VOC measurement, assessed 1 year - 15 years post diagnosis
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available