| Literature DB >> 31294132 |
Chang Wook Jeong1, Jungyo Suh1, Hyeong Dong Yuk1,2, Bum Sik Tae1,3, Miso Kim4, Bhumsuk Keam4, Jin Ho Kim5, Sang Youn Kim6, Jeong Yeon Cho6, Seung Hyup Kim6, Kyung Chul Moon7, Gi Jeong Cheon8, Ja Hyeon Ku1, Hyeon Hoe Kim1, Cheol Kwak1.
Abstract
Purpose: To establish a prospective, comprehensive, multidisciplinary, bio-bank linked genitourinary cancer cohort based on standard real practice. Materials andEntities:
Keywords: Biological specimen banks; Cohort studies; Prospective studies; Urogenital neoplasms
Year: 2019 PMID: 31294132 PMCID: PMC6607078 DOI: 10.4111/icu.2019.60.4.235
Source DB: PubMed Journal: Investig Clin Urol ISSN: 2466-0493
Sub-cohorts of the SUPER-GUC and their eligibility criteria
| Cohort | Eligibility criteria |
|---|---|
| SUPER-PC | |
| SUPER-PC-RP | Pathologically proven prostate cancer patients who undergo radical prostatectomy |
| SUPER-PC-AS | Pathologically proven low risk prostate cancer patients within 6 months who undergo active surveillance as initial treatment. They should be eligible by strict criteria registered in ClinicalTrials.gov protocol (NCT02971085), when patients want and meet usual active surveillance criteria they can be enrolled as non-strict criteria. |
| SUPER-PC-RT | Pathologically proven prostate cancer patients who undergo radiation therapy with curative intent. It includes primary, adjuvant and salvage radiation therapy, but palliative radiation therapy is not eligible. |
| SUPER-PC-HSPC | Pathologically proven non-metastatic or metastatic hormone sensitive prostate cancer patients who undergo medical therapy as major initial treatment. It includes watchful waiting, ADT and chemo-ADT. Neoadjuvant or adjuvant medical therapy for other major treatment is not eligible. |
| SUPER-PC-CRPC | Pathologically proven prostate cancer patients, who were progressed as CRPC within 3 months. |
| SUPER-RCC | |
| SUPER-RCC-Nx | Clinically diagnosed as renal cell carcinoma patients who undergo surgical treatment. It includes ablation, partial or radical nephrectomy. It is not limited to localized cancer, thus cytoreductive nephrectomy in metastatic disease is also eligible. |
| SUPER-RCC-mRCC | Pathologically proven renal cell carcinoma patients who were diagnosed as advanced (T4 or N1) or metastatic disease within 3 months and undergo initial treatment for advanced or metastatic RCC. Nephrectomy or metastasectomy before pathologic diagnosis does not limit the enrollment. |
| SUPER-UC | |
| SUPER-UC-TURB | Clinically diagnosed as bladder cancer patients who undergo transurethral resection of bladder tumor. |
| SUPER-UC-Cx | Pathologically proven bladder cancer patients who undergo radical cystectomy. |
| SUPER-UC-UTUC | Clinically diagnosed as upper urinary tract urothelial cancer patients who undergo curative surgical treatment for it. It includes nephroureterectomy, segmental ureterectomy and any kind of nephron sparing endoscopic treatment. It also includes definitive treatment plan after intraoperative decision by ureteroscopy with or without frozen biopsy. |
| SUPER-UC-mUC | Pathologically proven urothelial cancer patients who were diagnosed as advanced (non-localized or lymph node involve- ment) or metastatic disease within 3 months and undergo initial treatment for advanced or metastatic urothelial cancer. |
SUPER, Seoul National University Prospectively Enrolled Registry; GUC, Genitourinary Cancer; PC, prostate cancer; RP, radical prostatectomy; AS, active surveillance; RT, radiation therapy; HSPC, hormone-sensitive prostate cancer; ADT, androgen deprivation therapy; CRPC, castration-resistant prostate cancer; RCC, renal cell carcinoma; Nx, nephrectomy; mRCC, metastatic renal cell carcinoma; UC, urothelial cancer; TURB, transurethral resection of bladder tumor; Cx, cystectomy; UTUC, upper urinary tract urothelial cancer; mUC, metastatic urothelial cancer.
Architecture of electronic case-report forms for Seoul National University Prospectively Enrolled Registry for Prostate Cancer-Radical Prostatectomy (SUPER-PC-RP)
| Name of form | Number of fields | Entering type | Description and examples |
|---|---|---|---|
| Study data & demographics | 39 | Once entering | Study number, basic demographics and bio-banking information |
| Preop. characteristics | 54 | Once entering | Initial PSA, biopsy information, past medical, social and family history |
| Preop. imaging | 19 | Once entering | Results of magnetic resonance imaging and bone scan |
| Operation | 38 | Once entering | Details of surgery |
| Pathology | 50 | Once entering | Final pathology details |
| Postop. outcomes | 9 | Once entering | Short-term postoperative results such as duration of hospital stay, cystography and Foley catheter removal date |
| Complication | 31 | Once entering | Intraoperative, immediate, 30 and 90 days complications |
| Lab | 35 | Repeatedly entering | Laboratory results (except PSA) |
| PSA | 202 | Revisingly entering | PSA results |
| Medication & comorbidity | 22 | Repeatedly entering | Information of medication and comorbidity |
| A/E | 62 | Repeatedly entering | Post-treatment adverse events |
| IPSS | 14 | Repeatedly entering | International Prostate Symptom Score questionnaire |
| EPIC-CP | 26 | Repeatedly entering | Expanded Prostate Cancer Index Composite for Clinical Practice questionnaire |
| IIEF-5 | 9 | Repeatedly entering | International Index of Erectile Function-5 questionnaire |
| EQ-5D-5L | 10 | Repeatedly entering | EuroQol health-related utility measurement tool |
| CARE questionnaire | 35 | Repeatedly entering | Convalescence And Recovery Evaluation questionnaire |
| G8 | 10 | Once entering | Geriatric assessment by the G8 |
| InBody | 26 | Repeatedly entering | Body composition measurement by bio-electrical impedance analysis |
| Functional outcome summary | 30 | Revisingly entering | Summarized results of continence and potency |
| Oncologic outcome summary | 63 | Revisingly entering | Adjuvant or salvage treatment and oncologic outcome results |
Preop., preoperative; postop., postoperative; PSA, prostate-specific antigen.
Fig. 1Data collection process for the Seoul National University Prospectively Enrolled Registry for Prostate Cancer-Radical Prostatectomy (SUPER-PC–RP) with electronic case report forms. Preop., preoperative; character., characteristics; postop., postoperative; PO, postoperative; Qs, questionnaires; CARE, Convalescence And Recovery Evaluation; A/E, adverse events; PSA, prostate-specific antigen.
Patient enrollment status of Seoul National University Prospectively Enrolled Registry for Genitourinary Cancer (SUPER-GUC) at the end of December, 2018
| Cohort | First enrollment date | Number of patients |
|---|---|---|
| SUPER-PC | 929 | |
| SUPER-PC-RP | March 6, 2016 | 765 |
| SUPER-PC-AS | December 23, 2016 | 56 |
| SUPER-PC-RT | May 20, 2016 | 39 |
| SUPER-PC-HSPC | October 18, 2016 | 56 |
| SUPER-PC-CRPC | April 3, 2017 | |
| SUPER-RCC | 796 | |
| SUPER-RCC-Nx | March 10, 2016 | 762 |
| SUPER-RCC-mRCC | June 2, 2016 | 34 |
| SUPER-UC | 1,221 | |
| SUPER-UC-TURB | March 21, 2016 | 859 |
| SUPER-UC-Cx | March 21, 2016 | 170 |
| SUPER-UC-UTUC | March 7, 2016 | 163 |
| SUPER-UC-mUC | March 28, 2016 | 29 |
SUPER, Seoul National University Prospectively Enrolled Registry; PC, prostate cancer; RP, radical prostatectomy; AS, active surveillance; RT, radiation therapy; HSPC, hormone-sensitive prostate cancer; CRPC, castration-resistant prostate cancer; RCC, renal cell carcinoma; Nx, nephrectomy; mRCC, metastatic renal cell carcinoma; UC, urothelial cancer; TURB, transurethral resection of bladder tumor; Cx, cystectomy; UTUC, upper urinary tract urothelial cancer; mUC, metastatic urothelial cancer.
Participation, banking rates, and baseline characteristics of surgical sub-cohorts in SUPER-GUC
| Characteristic | SUPER-PC-RP | SUPER-RCC-Nx | SUPER-UC-TURB | SUPER-UC-Cx | SUPER-UC-UTUC |
|---|---|---|---|---|---|
| No. of patients enrolled | 765 | 762 | 859 | 170 | 163 |
| Participation ratea | 765/836 (91.5) | 762/853 (89.3) | 859/964 (89.1) | 170/191 (89.0) | 163/175 (93.1) |
| Bio-specimen sampling rate | 758/765 (99.1) | 733/762 (96.2) | 829/859 (96.5) | 155/170 (91.2) | 155/163 (95.1) |
| Tumor banking | 463/765 (60.5) | 565/762 (74.1) | 489/859 (56.9) | 117/170 (68.8) | 129/163 (79.1) |
| Baseline characteristics | |||||
| Age (y) | 68.7±6.6 | 59.4±12.4 | 68.9±11.9 | 67.0±10.9 | 68.5±9.9 |
| Sex | |||||
| Male | 765 (100.0) | 521 (68.4) | 687 (80.0) | 128 (75.3) | 113 (69.3) |
| Female | 0 (0.0) | 241(31.6) | 172 (20.0)b | 42 (24.7) | 50 (30.7) |
| Clinical T stage | |||||
| ≤T1 | 674 (88.1) | 658 (86.4) | 568 (66.1) | 59 (34.7) | 123 (75.5) |
| T2 | 79 (10.3) | 63 (8.3) | 86 (10.0)c | 88 (51.8) | 17 (10.4) |
| T3 | 12 (1.6) | 38 (5.0) | - | 15 (8.8) | 22 (13.5) |
| T4 | 0 (0.0) | 3 (0.4) | - | 8 (4.7) | 1 (0.6) |
| Tx | 0 (0.0) | 0 (0.0) | 205 (23.9)d | 0 (0.0) | 0 (0.0) |
| Clinical N stage | |||||
| N0 | 672 (87.8) | 738 (96.9) | - | 145 (85.3) | 145 (89.0) |
| N+ | 86 (11.2) | 24 (3.1) | - | 25 (14.7) | 18 (11.0) |
| Nx | 7 (0.9) | 0 (0.0) | - | 0 (0.0) | 0 (0.0) |
| Clinical M stage | |||||
| M0 | 738 (96.5) | 738 (96.9) | - | 169 (99.4) | 162 (99.4) |
| M+ | 0 (0.0) | 24 (3.1) | - | 1 (0.6) | 1 (0.6) |
| Mx | 27 (3.5) | 0 (0.0) | - | 0 (0.0) | 0 (0.0) |
Values are presented as number only, number/total number (%), mean±standard deviation, or number (%).
SUPER, Seoul National University Prospectively Enrolled Registry; GUC, Genitourinary Cancer; PC, prostate cancer; RP, radical prostatectomy; RCC, renal cell carcinoma; Nx, nephrectomy; UC, urothelial cancer; TURB, transurethral resection of bladder tumor; Cx, cystectomy; UTUC, upper urinary tract urothelial cancer.
a:Percentage of patients enrolled among all eligible patients, b:pathologic stage of first TURB after enrolled, c:pathologic stage ≥T2, d:pathologic T0 or benign.
Fig. 2Image captures of online interactive data visualization and analysis platform for Seoul National University Prospectively Enrolled Registry for Prostate Cancer-Radical Prostatectomy (SUPER-PC-RP). Dashboards are interactively changed when dimensional variables are changed in left panel. (A) Enrollment status, (B) operative methods and results, (C) pathologic outcomes, (D) example of interactive analysis. Pathologic Gleason Score by operative type and D'Amico classification.