HealthyNCT00838747
Measurement of the Folate Receptor in Blood
An observational study of Healthy, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The folate receptor (FR) is a cell marker that is over expressed on the cell 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?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2008to Jul 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ovarian cancer and healthy volunteers
Who may be able to join
- Patients with stage III/IV ovarian cancer
- healthy volunteers who are staff at the ICR and RMH
Who cannot join
- patients or healthy volunteers who are unable to give informed consent
- pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Marsden NHS Foundation Trust
London, Sutton, SM2 5PT
About this study
The folate receptor (FR) is a cell marker that is over expressed on the cell 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 achieve anti-tumour efficacy whilst 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. One such drug BGC 945 is currently being tested in preclinical study at The Institute of Cancer Research
Read the detailed description
A method has been developed in the laboratory which has been able to measure FR obtained from cancer cells in culture that has been added into blood. We would like to study if this method can measure FR in plasma and serum obtained from patients with ovarian cancer. We would also like to analyse plasma and serum samples obtained from healthy volunteers to determine if they have any appreciable levels of FR, which can then be compared to the measurements obtained from cancer patients.
- Conditions
- Healthy
- Keywords
- folate receptor, blood samples, ovarian cancer, development of measure of folate receptor in blood samples, possible selection of patients for treatment with FR targeted agents
- Medical subject headings
- Ovarian Neoplasms
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 |
|---|---|---|
| Gynaecological Cancer | Gynaecological Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the levels of folate receptor in blood samples obtained from patients with ovarian cancer and from healthy volunteers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionJan 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stan Kaye, Professor, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838747
- Sponsor's protocol ID
- CCR3028
- Status last verified
- May 2016
- First submitted
- 5 Sep 2008
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Folate Receptor in Blood
- ClinicalTrials.gov ID
- NCT00838747
- Acronym / sponsor ID
- CCR3028
- Conditions
- Healthy
- Keywords
- folate receptor, blood samples, ovarian cancer, development of measure of folate receptor in blood samples, possible selection of patients for treatment with FR targeted agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Feb 2009 (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 marker that is over expressed on the cell 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 achieve anti-tumour efficacy whilst 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. One such drug BGC 945 is currently being tested in preclinical study at The Institute of Cancer Research
Detailed description
A method has been developed in the laboratory which has been able to measure FR obtained from cancer cells in culture that has been added into blood. We would like to study if this method can measure FR in plasma and serum obtained from patients with ovarian cancer. We would also like to analyse plasma and serum samples obtained from healthy volunteers to determine if they have any appreciable levels of FR, which can then be compared to the measurements obtained from cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynaecological Cancer | – | –Gynaecological Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ovarian cancer and healthy volunteers
Key inclusion criteria (2 listed)
- Patients with stage III/IV ovarian cancer
- healthy volunteers who are staff at the ICR and RMH
Key exclusion criteria (2 listed)
- patients or healthy volunteers who are unable to give informed consent
- pregnancy
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 folate receptor in blood samples obtained from patients with ovarian cancer and from healthy volunteers
Time frame: 1 year
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 26 May 2016.
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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.
Stan Kaye, Professor principal investigator
Royal Marsden NHS Foundation Trust
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 Healthy, 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 2 inclusion and 2 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 26 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 folate receptor in blood samples obtained from patients with ovarian cancer and from healthy volunteers (time frame: 1 year). 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 26 May 2016.