Spectroscopy in Ovarian Cancer

May 7, 2024 updated by: University of Exeter

Molecular Spectroscopy in Identification and Assessment of Ovarian Cancer

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to secondary care with suspected ovarian cancer symptoms. Patients with likely ovarian cancer, yet to start definitive treatment.

Description

Inclusion Criteria:

  • Female
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Suspected Ovarian Cancer
Patients referred or self presenting to secondary care with signs or symptoms of ovarian cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years
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.
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Exeter

Collaborators

University Hospitals Bristol and Weston NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2021

Primary Completion (Actual)

October 1, 2023

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-21-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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