Spectroscopy in Ovarian Cancer

Active, not recruiting

• Conditions: Ovary Cyst; Ovarian Cancer; Ovarian Neoplasms; Ovary Disease

• Registration Number: NCT04817449
• Lead Sponsor: University of Exeter

Brief Summary

Ovarian cancer is the eighth most common cause of cancer death in the world. Advanced stage at diagnosis is associated with lower survival rates, thus early detection appears to have an important role.

Raman Spectroscopy is a non-invasive technique that uses the interaction of light to identify the composition of the sample tested.

The aim of the project is to explore the use of spectroscopic techniques in the detection of ovarian cancer. There are two different assessments within the project:

1. Identify ovarian cancer in blood - Raman spectroscopic analysis will be performed on blood plasma taken from patients with suspected ovarian cancer.

2. Detect active cancer within post chemotherapy fibrotic tissue - Ex vivo Raman spectroscopic analysis of peritoneal, omental or ovarian tissues collected from patients undergoing surgical treatment for ovarian cancer.

The results of the spectroscopy will be correlated to clinical outcome and histological diagnosis respectively.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-26
• Study Start: 2021-06-28
• Primary Completion: 2023-10-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• Female
• Symptoms suggestive of ovarian cancer
• Patients undergoing treatment of Ovarian Cancer

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Exclusion Criteria

• Less than 18 years of age
• Unable to consent to the study due to communication difficulties
• Unable to consent to the study due to lack of capacity

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ascertain the diagnostic performance of vibrational spectroscopy for detection of Ovarian Cancer	2 years	Biomarkers for ovarian cancer will be identified by analysing Raman spectral data of plasma samples taken from patient with ovarian cancer symptoms. Clinical outcome of cancer/no cancer will be used to correlate the results.
Ascertain the discriminatory ability of vibrational spectroscopy to differentiate between normal, fibrotic and cancerous tissue	2 years	Samples taken from post chemotherapy patients will be analysed to identify the spectral signature of ovarian cancer in chemotherapy exposed tissue.

Secondary Outcome Measures

Name	Time	Method
Performance of vibrational spectroscopy in recurrence prediction	2 years	Plasma samples after recurrence of cancer will be analysed and compared to initial spectral signature at diagnosis
Performance of vibrational spectroscopy in chemotherapy response prediction	2 years	Plasma samples after 1st cycle of chemotherapy will be analysed to evaluate for changes in biomarkers after chemotherapy treatment.

Trial Locations

Locations (1)

University Hospitals Bristol and Weston NHS Trust; 🇬🇧 Bristol, United Kingdom