NCT04817449

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. 1.Identify ovarian cancer in blood - Raman spectroscopic analysis will be performed on blood plasma taken from patients with suspected ovarian cancer.
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 28, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

March 4, 2021

Last Update Submit

December 12, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Performance of vibrational spectroscopy in chemotherapy response prediction

    2 years

  • Performance of vibrational spectroscopy in recurrence prediction

    2 years

Study Arms (1)

Suspected Ovarian Cancer

Patients referred or self presenting to secondary care with signs or symptoms of ovarian cancer.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Bristol and Weston NHS Trust

Bristol, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Histological sections of tissue specimens of ovary, omentum or peritoneum Blood

MeSH Terms

Conditions

Ovarian NeoplasmsOvarian CystsOvarian Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCysts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 26, 2021

Study Start

June 28, 2021

Primary Completion

October 1, 2023

Study Completion

October 30, 2025

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations