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Measurement of the Folate Receptor in Blood

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ClinicalTrials.gov Identifier: NCT00838747
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief 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. 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

Condition or disease
Healthy

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 Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of the Folate Receptor in Blood
Study Start Date : September 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Group/Cohort
Gynaecological Cancer
Gynaecological Cancer



Primary Outcome Measures :
  1. To measure the levels of folate receptor in blood samples obtained from patients with ovarian cancer and from healthy volunteers [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with ovarian cancer and healthy volunteers
Criteria

Inclusion Criteria:

  • Patients with stage III/IV ovarian cancer
  • healthy volunteers who are staff at the ICR and RMH

Exclusion Criteria:

  • patients or healthy volunteers who are unable to give informed consent
  • pregnancy

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838747


Locations
United Kingdom
Royal Marsden NHS Foundation Trust
London, Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Stan Kaye, Professor Royal Marsden NHS Foundation Trust

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00838747     History of Changes
Other Study ID Numbers: CCR3028
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016

Keywords provided by Royal Marsden NHS Foundation Trust:
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

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs