Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001138279
Ethics application status
Approved
Date submitted
2/07/2018
Date registered
11/07/2018
Date last updated
14/06/2019
Date data sharing statement initially provided
14/06/2019
Date results information initially provided
14/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing methylene tetrahydrofolate reductase (MTHFR) genetic polymorphisms and dietary folate intake in platinum resistant and platinum sensitive ovarian patients
Scientific title
A retrospective cross-sectional cohort trial assessing the implications of MTHFR polymorphisms on DNA methylation and platinum resistance in ovarian cancer patients
Secondary ID [1] 295351 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian cancer 308570 0
MTHFR gene polymorphisms 308572 0
Condition category
Condition code
Cancer 307527 307527 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The project is aimed at assessing MTHFR polymorphism prevalence in platinum resistance versus platinum sensitive ovarian cancer patients. Participants will be allocated into platinum resistant/refractory or platinum sensitive groups based on their clinical diagnosis by their treating oncologist following first line platinum drug therapy. Secondary assessment of folate dietary intake through natural and synthetic sources will be conducted using a food frequency questionnaire developed by the Cancer Council Victoria based on the previous 12 months, analysing overall differences in intake between the groups, as well as differences between intake prior to and after diagnosis. Both primary and secondary observations will be used to identify any association between genetic or nutrigenomic influence in platinum drug response in ovarian cancer patients. A single interview will be conducted to collect a thorough medical and family history that will take approximately 1 hour. Participants will also be asked to consent to the use of their medical records for information regarding diagnosis and medical history.
Intervention code [1] 301674 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306536 0
MTHFR polymorphism prevalence.
Timepoint [1] 306536 0
Blood serum samples taken on single testing day.
Secondary outcome [1] 348803 0
To investigate folate intake (epigenetic or direct impact on cancer progression) and difference between platinum resistant and platinum sensitive ovarian cancer patients through a food frequency questionnaire.
Timepoint [1] 348803 0
Food Frequency Questionnaire filled out on single testing day.
Secondary outcome [2] 348804 0
Investigate possible genetic or nutrigenomic influence on platinum drug response from an exploratory perspective.
Timepoint [2] 348804 0
Exploratory outcome.

Eligibility
Key inclusion criteria
• Diagnosed with ovarian, fallopian tube, epithelial or peritoneal cancer
• Completed first line platinum therapy
• Diagnosed with refractory/resistant disease or platinum sensitive disease a minimum of 6 months after platinum therapy
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Non-English speaking
• Never received a platinum drug for ovarian cancer diagnosis

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Based on previous research and 'central limit theory', a sample size of 29 participants will report a confidence level of 95%. By selecting a sample size of 30 participants for the study, this would reflect a confidence interval of 17.89%. In the event that 70% of participants have an MTHFR mutation, as has been suggested by world-wide population estimates, the investigators can be confident that between 52.11% and 87.89% of the sample will contain an accurate reflection of possibility, equating to between 16 and 26 participants showing some correlation.
All data will be analysed on STATA ©14. Associations between variables such as the presence or absence of MTHFR polymorphisms will be subject to the chi-square test. Logistic regression will be applied to determine the correlation between the existence and/or absence of any of the test variables (folate intake and/or MTHFR polymorphisms) and platinum response. Further analysis may occur once all variables are determined.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/08/2018
Actual
11/09/2018
Date of last participant enrolment
Anticipated
10/09/2018
Actual
6/12/2018
Date of last data collection
Anticipated
14/09/2018
Actual
18/12/2018
Sample size
Target
30
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11284 0
Icon Cancer Care Southport - Southport
Recruitment hospital [2] 11291 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment postcode(s) [1] 23173 0
4215 - Southport
Recruitment postcode(s) [2] 23179 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 299943 0
University
Name [1] 299943 0
Endeavour College of Natural Health
Country [1] 299943 0
Australia
Funding source category [2] 299969 0
Self funded/Unfunded
Name [2] 299969 0
Dr Janet Schloss
Country [2] 299969 0
Australia
Primary sponsor type
University
Name
Endeavour College of Natural Health
Address
Level 2, 269 Wickham Street, Fortitude Valley Brisbane, QLD Australia 4006
Country
Australia
Secondary sponsor category [1] 299350 0
None
Name [1] 299350 0
Address [1] 299350 0
Country [1] 299350 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300810 0
Endeavour College of Natural Health Human Research and Ethics Committee
Ethics committee address [1] 300810 0
Level 2, 269 Wickham Street, Fortitude Valley Brisbane, QLD Australia 4006
Ethics committee country [1] 300810 0
Australia
Date submitted for ethics approval [1] 300810 0
08/06/2018
Approval date [1] 300810 0
05/07/2018
Ethics approval number [1] 300810 0
20180609

Summary
Brief summary
The purpose of this study is to determine the presence of methylene tetrahydrofolate reductase (MTHFR) genetic polymorphisms in platinum resistance and platinum sensitive ovarian cancer patients.
Who is it for?
You may be eligible for this study if you are an adult who has been diagnosed with ovarian, fallopian tube, epithelial or peritoneal cancer.
Study details:
Participants will be asked to undertake a single blood test and complete the food frequency questionnaire designed by the Cancer Council Victoria. A single interview will also be conducted in order to record a thorough medical and family history, that will take approximately 1 hour. Participants will also be asked to consent to the use of their medical records for information regarding diagnosis and medical history.
The project is aimed at providing an insight into the influence of diet in platinum responsiveness in ovarian cancer, and whether MTHFR status can be used as a prognostic biomarker for clinical decisions regarding treatment strategy, for patients at risk of platinum drug toxicity or poor responsiveness.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2852 2852 0 0
/AnzctrAttachments/375457-Protocol Final.docx (Protocol)

Contacts
Principal investigator
Name 84886 0
Mrs Caitlin Phillips Chavez
Address 84886 0
ICON Cancer Care Southport, Level 9, 39 White Street Southport, QLD 4215
Country 84886 0
Australia
Phone 84886 0
+61 7 5657 6480
Fax 84886 0
Email 84886 0
[email protected]
Contact person for public queries
Name 84887 0
Dr Janet Schloss
Address 84887 0
Endeavour College of Natural Health Research, Level 2, 269 Wickham Street, Fortitude Valley Brisbane, QLD 4006
Country 84887 0
Australia
Phone 84887 0
+61 7 3253 9579
Fax 84887 0
Email 84887 0
[email protected]
Contact person for scientific queries
Name 84888 0
Dr Janet Schloss
Address 84888 0
Endeavour College of Natural Health Research, Level 2, 269 Wickham Street, Fortitude Valley Brisbane, QLD 4006
Country 84888 0
Australia
Phone 84888 0
+61 7 3253 9579
Fax 84888 0
Email 84888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 375457-(Uploaded-14-06-2019-14-19-49)-Basic results summary.docx
Plain language summaryNo The results of this trial revealed strong associat... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA retrospective cross-sectional cohort trial assessing the prevalence of MTHFR polymorphisms and the influence of diet on platinum resistance in ovarian cancer patients.2021https://dx.doi.org/10.3390/cancers13205215
N.B. These documents automatically identified may not have been verified by the study sponsor.