Spectroscopy in Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Molecular Spectroscopy in Identification and Assessment of Ovarian Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04817449
• Other study ID #: 2020-21-12
• Status: Active, not recruiting
• Start date: June 28, 2021
• Est. completion date: October 2024

Study information

• Verified date: June 2024
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: October 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Ovary Cyst
• Ovary Disease

Locations

Country	Name	City	State
United Kingdom	University Hospitals Bristol and Weston NHS Trust	Bristol

Sponsors (2)

Lead Sponsor	Collaborator
University of Exeter	University Hospitals Bristol and Weston NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ascertain the diagnostic performance of vibrational spectroscopy for detection of Ovarian Cancer	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
Primary	Ascertain the discriminatory ability of vibrational spectroscopy to differentiate between normal, fibrotic and cancerous tissue	Samples taken from post chemotherapy patients will be analysed to identify the spectral signature of ovarian cancer in chemotherapy exposed tissue.	2 years
Secondary	Performance of vibrational spectroscopy in chemotherapy response prediction	Plasma samples after 1st cycle of chemotherapy will be analysed to evaluate for changes in biomarkers after chemotherapy treatment.	2 years
Secondary	Performance of vibrational spectroscopy in recurrence prediction	Plasma samples after recurrence of cancer will be analysed and compared to initial spectral signature at diagnosis	2 years