Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Location contact
Andreana N Holowatyj, PhD, MSCI
PRINCIPAL_INVESTIGATOR
PREFACE Study Coordinator (Rebecca B.)
CONTACT
NCT Number: NCT05239338
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.
Interested in participating?
Request Info18 year–49 year
All sexes
Observational
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Andreana N Holowatyj, PhD, MSCI
PRINCIPAL_INVESTIGATOR
PREFACE Study Coordinator (Rebecca B.)
CONTACT
The Preserving Fertility After Colorectal Cancer (PREFACE) Study comprehensively investigates fertility, sexual health and clinical outcomes along the cancer care continuum among individuals diagnosed with colorectal cancer between age 18 to 49 years.
Patients are recruited prior to colorectal cancer therapy [baseline] and followed for up to 36 months after completion of first-course therapy (or 45 months after diagnosis for patients on maintenance therapy). Study timepoints are defined at: (i) completion of first-course treatment (or 9 months after diagnosis for patients on maintenance therapy [treatment]); (ii) and at 9, 18 and 36 month intervals thereafter [surveillance]. This cohort is enriched by a robust collection of biospecimens and data.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline, treatment and multiple surveillance timepoints (up to 5 years)
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 timepoint
Time frame: Baseline, treatment and multiple surveillance timepoints (up to 5 years)
Time frame: Baseline timepoint
Time frame: Baseline, treatment and multiple surveillance timepoints (Up to 5 years)
Time frame: 9 month post-treatment/Surveillance timepoint
Time frame: Up to 5 years
Time frame: At baseline, treatment and multiple surveillance timepoints (Up to 5 years)
Time frame: Baseline timepoint
Time frame: Completion of first-course treatment (or 9 months after baseline)
Time frame: 9 month post-treatment/Surveillance timepoint
Time frame: 18 month post-treatment/Surveillance timepoint
Time frame: 36 month post-treatment/Surveillance timepoint
Contact information is provided by the study sponsor or research team.
Andreana Holowatyj, PhD, MSCI
Other
Preserving Fertility After Colorectal Cancer: The PREFACE Study
Acronym: PREFACE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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