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Clinical Trials/NCT04817449
NCT04817449
Completed
Not Applicable

Molecular Spectroscopy in Identification and Assessment of Ovarian Cancer

University of Exeter1 site in 1 country160 target enrollmentJune 28, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Cancer
Sponsor
University of Exeter
Enrollment
160
Locations
1
Primary Endpoint
Ascertain the diagnostic performance of vibrational spectroscopy for detection of Ovarian Cancer
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 28, 2021
End Date
October 30, 2025
Last Updated
4 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

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

Outcomes

Primary Outcomes

Ascertain the diagnostic performance of vibrational spectroscopy for detection of Ovarian Cancer

Time Frame: 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

Time Frame: 2 years

Samples taken from post chemotherapy patients will be analysed to identify the spectral signature of ovarian cancer in chemotherapy exposed tissue.

Secondary Outcomes

  • Performance of vibrational spectroscopy in recurrence prediction(2 years)
  • Performance of vibrational spectroscopy in chemotherapy response prediction(2 years)

Study Sites (1)

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