ColoCare Data Warehouse
The ColoCare Study has a virtual, centralized data warehouse which coordinates data acquisition, integration, secure sharing, and access, while implementing high standards. The ColoCare Data Warehouse domains include demographic information, patient recruitment and follow-up, biometrics, diagnosis, treatments and outcomes, questionnaires, and biorepository. The ColoCare Data Warehouse will be the primary source for sharing ColoCare Study data, outlined below.
Types of Study Data Available
- Questionnaire data are collected directly from participants in the ColoCare Study. These include data that may not be available routinely in medical records such as diet and supplement use; physical activity and derived data such as energy expenditure estimates; individual-level socioeconomic status variables such as educational attainment; quality of life and depression; social support; self-reported outcomes, e.g., recurrences; and other domains.
- Clinical data include data from medical records.
- Outcomes data include data on recurrence or progression, deaths and cause of death, and potentially other outcomes such as time to treatment or comorbid conditions.
- Biospecimens include tumor and normal tissue, blood samples, urine samples, stool samples, and saliva samples (at some sites) at repeat time points. Biospecimens will be made available to researchers who are interested in requesting biospecimens as part of a research project request. The metadata on biospecimen availability will help external researchers plan potential projects and could be used for power calculations.
ColoCare Patient Characteristics
The patient characteristics of the ColoCare Study recruited at six US sites and one German site as of January 31, 2023 are provided below.
| ColoCare Patient Characteristics as of January 31, 2023 | |
|---|---|
| Patient Characteristics* | Total (N=3,715) |
| Age at diagnosis, n (%) | |
| ≤ 39 | 265 (7%) |
| 40-49 | 610 (16%) |
| 50 | 114 (3%) |
| 51-59 | 879 (24%) |
| 60-69 | 1001 (27%) |
| ≥70 | 846 (23%) |
| Sex, n (%) | |
| Male | 2055 (55%) |
| Female | 1660 (45%) |
| Race, n (%) | |
| American Indian/Alaska Native | 23 (1%) |
| Asian | 111 (3%) |
| Native Hawaiian/ Pacific Islander | 14 (0%) |
| Black or African American | 282 (8%) |
| White | 3188 (86%) |
| More than One Race | 32 (1%) |
| Other | 44 (1%) |
| Unknown | 14 (0%) |
| Did not answer | 0 (0%) |
| Pending / To be abstracted | 7 (0%) |
| Ethnicity, n (%) | |
| Not Hispanic | 3512 (95%) |
| Hispanic or Latino | 163 (4%) |
| Unknown | 34 (1%) |
| Did not answer | 0 (0%) |
| Pending / To be abstracted | 6 (0%) |
| Tumor Location, n (%) | |
| Colon | 1902 (51%) |
| Rectum and Rectosigmoid | 1733 (47%) |
| Pending / To be abstracted | 80 (2%) |
| Tumor Stage at Diagnosis, n (%)† | |
| I | 563 (15%) |
| II | 788 (21%) |
| III | 1185 (32%) |
| IV | 647 (17%) |
| 0/In situ/polyps | 132 (4%) |
| Pending / To be abstracted | 400 (11%) |
| Primary Surgery, n (%) | |
| Yes | 3307 (89%) |
| No | 226 (6%) |
| Pending / To be abstracted | 182 (5%) |
| Resection Status, n (%)** | |
| R0 (Margins clear) | 2329 (63%) |
| R1/R2 (Tumor cells in margins) | 164 (4%) |
| Rx | 183 (5%) |
| Pending / To be abstracted | 1039 (28%) |
| Neoadjuvant Treatment, n (%) | |
| Colon | 224 (6%) |
| Rectum and Rectosigmoid | 992 (27%) |
| Pending / To be abstracted | 2 (0%) |
| Adjuvant Treatment, n (%) | |
| Colon | 795 (21%) |
| Rectum and Rectosigmoid | 660 (18%) |
| Pending / To be abstracted | 1 (0%) |
| Body Mass Index (BMI), n (%) | |
| Underweight (< 18.5) | 71 (2%) |
| Normal Weight (18.5-24.9) | 937 (25%) |
| Overweight (25.0-29.9) | 1246 (34%) |
| Obese (>30.0) | 1178 (32%) |
| Pending / To be abstracted | 283 (8%) |
| Residency, n (%)*** | |
| Rural | 379 (19%) |
| Urban | 1447 (73%) |
| Pending / To be abstracted | 67 (NA%) |
*Recruited at six US sites (HCI, Moffitt, FredHutch, Cedars, WashU, and Tennessee) and one German site (Heidelberg).
†Clinical stage for patients receiving neoadjuvant therapy; Pathological stage for all others
**Due to off-site surgery, the sum of resection status may not equal the number of primary resections.
***Information on Urban/Rural area available for US sites only (n=1,988).
