Ovarian CancerNCT04817449
Spectroscopy in Ovarian Cancer
An observational study of Ovarian Cancer and Ovarian Neoplasms, run by University of Exeter at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer, Ovarian Neoplasms, Ovary Cyst
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2021to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting to secondary care with suspected ovarian cancer symptoms. Patients with likely ovarian cancer, yet to start definitive treatment.
Who may be able to join
- Female
- Symptoms suggestive of ovarian cancer
- Patients undergoing treatment of Ovarian Cancer
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Bristol and Weston NHS Trust
Bristol
About this study
Official title: 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.
Read more
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:
- Identify ovarian cancer in blood - Raman spectroscopic analysis will be performed on blood plasma taken from patients with suspected ovarian cancer.
- 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.
- Conditions
- Ovarian Cancer, Ovarian Neoplasms, Ovary Cyst, Ovary Disease
- Medical subject headings
- Ovarian Neoplasms, Ovarian Cysts, Ovarian Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suspected Ovarian Cancer | Patients referred or self presenting to secondary care with signs or symptoms of ovarian cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 2 years
Performance of vibrational spectroscopy in recurrence prediction
Plasma samples after recurrence of cancer will be analysed and compared to initial spectral signature at diagnosis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start28 Jun 2021
- Primary completion1 Oct 2023
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Bristol and Weston NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817449
- Sponsor's protocol ID
- 2020-21-12
- Status last verified
- Dec 2025
- First submitted
- 4 Mar 2021
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Spectroscopy in Identification and Assessment of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04817449
- Acronym / sponsor ID
- 2020-21-12
- Conditions
- Ovarian Cancer, Ovarian Neoplasms, Ovary Cyst, Ovary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- University Hospitals Bristol and Weston NHS Foundation Trust
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Identify ovarian cancer in blood - Raman spectroscopic analysis will be performed on blood plasma taken from patients with suspected ovarian cancer.
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected Ovarian Cancer | – | –Patients referred or self presenting to secondary care with signs or symptoms of ovarian cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to secondary care with suspected ovarian cancer symptoms. Patients with likely ovarian cancer, yet to start definitive treatment.
Key inclusion criteria (3 listed)
- Female
- Symptoms suggestive of ovarian cancer
- Patients undergoing treatment of Ovarian Cancer
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Performance of vibrational spectroscopy in chemotherapy response prediction
Time frame: 2 years
Performance of vibrational spectroscopy in recurrence prediction
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Ovarian Neoplasms, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ascertain the diagnostic performance of vibrational spectroscopy for detection of Ovarian Cancer (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.