Preserving Fertility After Colorectal Cancer Study
ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-49
SponsorAndreana Holowatyj, PhD, MSCI
About this trial
The PREFACE Study is a prospective, longitudinal cohort study of reproductive health and clinical outcomes among individuals diagnosed with colorectal cancer between age 18 to 49 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Known diagnosis of colorectal cancer
Age 18 to 49 years at colorectal cancer diagnosis
Diagnosed by and/or consulting with a physician participating in the PREFACE Study
No prior history of colorectal cancer and/or colorectal cancer treatment
Disqualifiers
Women who are pregnant at the time of colorectal cancer diagnosis
Prisoners
Unable to provide informed consent
Unable to read, write, or complete questionnaires in English
Trial population
Individuals diagnosed with colorectal cancer between the ages of 18 to 49 years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: PREFACE: Vanderbilt-Ingram Cancer Center
Trial outcomes
Primary outcomes
1
Change(s) in serum hormonal markers
For female patients not taking oral contraceptive pills (OCPs), serum hormonal markers to be measured include: anti-Mullerian hormone (AMH), estrogens, sex hormone binding globulin (SHBG), follicle-stimulating hormone (FSH), luteinizing hormone (LH) and androgens. For male patients, serum hormonal markers to be measured include: inhibin B, FSH, androgens, estrogens, SHBG and LH.
Time frame
Baseline, treatment and multiple surveillance timepoints (up to 5 years)2
Reproductive health history (Questionnaire)
Time frame
Baseline timepoint3
Change(s) in reproductive health (Questionnaire)
Time frame
Baseline, treatment and multiple surveillance timepoints (up to 5 years)4
Sexual health history (Questionnaire)
Time frame
Baseline timepointSecondary outcomes
1
Change(s) in health-related quality of life (Questionnaire)
Time frame
At baseline, treatment and multiple surveillance timepoints (Up to 5 years)2
Physical activity (Accelerometer)
Time frame
Baseline timepoint3
Physical activity (Accelerometer)
Time frame
Completion of first-course treatment (or 9 months after baseline)4
Physical activity (Accelerometer)
Time frame
9 month post-treatment/Surveillance timepointSponsors and contacts
Click on the lead sponsor to view all of their trials.
Andreana Holowatyj, PhD, MSCI
Lead sponsor
Vanderbilt-Ingram Cancer Center
Sponsor institution
Source ClinicalTrials.gov