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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREFACE: Vanderbilt-Ingram Cancer Center | Patient recruitment and follow-up, longitudinal collection of data and multiple biospecimen at pre-defined study timepoints, objective assessment of health behaviors/habits, individual interviews. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, treatment and multiple surveillance timepoints (up to 5 years) |
| Reproductive health history (Questionnaire) | Baseline timepoint | |
| Change(s) in reproductive health (Questionnaire) | Baseline, treatment and multiple surveillance timepoints (up to 5 years) | |
| Sexual health history (Questionnaire) | Baseline timepoint | |
| Changes in sexual health (Questionnaire) | Baseline, treatment and multiple surveillance timepoints (Up to 5 years) | |
| Sexual health (Interview) | 9 month post-treatment/Surveillance timepoint | |
| Disease-free survival | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change(s) in health-related quality of life (Questionnaire) | At baseline, treatment and multiple surveillance timepoints (Up to 5 years) | |
| Physical activity (Accelerometer) | Baseline timepoint | |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals diagnosed with colorectal cancer between the ages of 18 to 49 years.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PREFACE Study Coordinator (Rebecca B.) | Contact | 615-936-6204 | prefacestudy@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Andreana N Holowatyj, PhD, MSCI | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Recruiting | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34554830 | Background | Holowatyj AN, Eng C, Lewis MA. Incorporating Reproductive Health in the Clinical Management of Early-Onset Colorectal Cancer. JCO Oncol Pract. 2022 Mar;18(3):169-172. doi: 10.1200/OP.21.00525. Epub 2021 Sep 23. No abstract available. | |
| 35090673 | Background | Eng C, Jacome AA, Agarwal R, Hayat MH, Byndloss MX, Holowatyj AN, Bailey C, Lieu CH. A comprehensive framework for early-onset colorectal cancer research. Lancet Oncol. 2022 Mar;23(3):e116-e128. doi: 10.1016/S1470-2045(21)00588-X. Epub 2022 Jan 31. |
| Label | URL |
|---|---|
| PREFACE Study Website | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Physical activity (Accelerometer) |
| Completion of first-course treatment (or 9 months after baseline) |
| Physical activity (Accelerometer) | 9 month post-treatment/Surveillance timepoint |
| Physical activity (Accelerometer) | 18 month post-treatment/Surveillance timepoint |
| Physical activity (Accelerometer) | 36 month post-treatment/Surveillance timepoint |
| 39531236 | Background | Keller SR, Rosen A, Lewis MA, Park HK, Babyak R, Feldman J, Ye F, Agarwal R, Ciombor KK, Geiger TM, Eng C, Hunzinger KJ, Viskochil RH, Roach MK, Velez Edwards DR, Cote ML, Holowatyj AN. Patient-Reported Discussions on Fertility Preservation Before Early-Onset Cancer Treatment. JAMA Netw Open. 2024 Nov 4;7(11):e2444540. doi: 10.1001/jamanetworkopen.2024.44540. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |