Ovarian CancerNCT00787514
FR in Stored Plasma
An observational study of Ovarian Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The folate receptor (FR) is a cell over expressed on the surface of certain cancers, this occurs most frequently in ovarian cancers. Some normal tissues also express the FR, however in these normal tissues, the FR is usually located on the tissue surface that is inaccessible to circulating drugs. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2008to Feb 2011
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: In the first stage of the study 13 samples will be analysed. If thee is one or more positive results the study will progress to the 2nd state to include 14 more samples.
Who may be able to join
- Patients with ovarian cancer who have given informed consent to have blood collected for the plasma bank in the 'Pharmacogenetics and proteomics studies in patients receiving novel anticaner agents' study.
Who cannot join
- Patients who have withdrawn consent form their blood stored within the 'Pharmacogenetics and proteomics studies in patients receiving novel anticancer agents' study to be used for research.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: Measurement of the Folate Receptor in Stored Plasma From Patients With Ovarian Cancer
The folate receptor (FR) is a cell over expressed on the surface of certain cancers, this occurs most frequently in ovarian cancers. Some normal tissues also express the FR, however in these normal tissues, the FR is usually located on the tissue surface that is inaccessible to circulating drugs. As such, drugs which target the FR may potentially be used to target cancers which overexpress the FR while reducing toxicity to normal tissues. Therefore the ability to measure FR levels from different cancer types may help to select patients who are most likely to benefit from treatment with FR targeted therapies. Once such drug BGC945 is currently being tested in preclinical study at the Institute of Cancer Research
Read the detailed description
FR may be released from the cancer cells in the blood. We have developed a method in the laboratory which has been able to measure the FR obtained from cancer cells in culture which has been added into blood. We would like to study if this method is able to measure the FR in stored plasma samples obtained from patients with ovarian cancer, so that it may be developed as a method for selecting patients for FR-target treatments such as BGC 945.
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, folate receptor, plasma
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the levels of soluble folate receptor in stored plasma obtained from patients with ovarian cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2011
- Study completionFeb 2011
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.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787514
- Sponsor's protocol ID
- CCR3029
- Status last verified
- Nov 2008
- First submitted
- 6 Nov 2008
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Folate Receptor in Stored Plasma From Patients With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00787514
- Acronym / sponsor ID
- CCR3029
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, folate receptor, plasma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
- Study start
- Jul 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 7 Nov 2008 (estimated)
- 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.
The folate receptor (FR) is a cell over expressed on the surface of certain cancers, this occurs most frequently in ovarian cancers. Some normal tissues also express the FR, however in these normal tissues, the FR is usually located on the tissue surface that is inaccessible to circulating drugs. As such, drugs which target the FR may potentially be used to target cancers which overexpress the FR while reducing toxicity to normal tissues. Therefore the ability to measure FR levels from different cancer types may help to select patients who are most likely to benefit from treatment with FR targeted therapies. Once such drug BGC945 is currently being tested in preclinical study at the Institute of Cancer Research
Detailed description
FR may be released from the cancer cells in the blood. We have developed a method in the laboratory which has been able to measure the FR obtained from cancer cells in culture which has been added into blood. We would like to study if this method is able to measure the FR in stored plasma samples obtained from patients with ovarian cancer, so that it may be developed as a method for selecting patients for FR-target treatments such as BGC 945.
Study design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In the first stage of the study 13 samples will be analysed. If thee is one or more positive results the study will progress to the 2nd state to include 14 more samples.
Key inclusion criteria (1 listed)
- Patients with ovarian cancer who have given informed consent to have blood collected for the plasma bank in the 'Pharmacogenetics and proteomics studies in patients receiving novel anticaner agents' study.
Key exclusion criteria (1 listed)
- Patients who have withdrawn consent form their blood stored within the 'Pharmacogenetics and proteomics studies in patients receiving novel anticancer agents' study to be used for research.
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
To measure the levels of soluble folate receptor in stored plasma obtained from patients with ovarian cancer
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 23 May 2016.
Related trials for Ovarian Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2
WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
Epithelial Ovarian Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
Solid Tumor, Metastatic Ovary Cancer
RecruitingObservational study
Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer
Ovarian Cancer, BRCA Mutation
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, run by Royal Marsden NHS Foundation Trust 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 1 inclusion and 1 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 23 May 2016. 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?
To measure the levels of soluble folate receptor in stored plasma obtained from patients with ovarian cancer. 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 23 May 2016.