NCT01117779 (TRACE) is a clinical trial of Cryoablation in Kidney Neoplasms, sponsored by Boston Scientific Corporation.

Who is sponsoring NCT01117779?

NCT01117779 is sponsored by Boston Scientific Corporation.

What drugs are being tested in NCT01117779?

Interventions in NCT01117779: Cryoablation.

What condition does NCT01117779 study?

NCT01117779 studies Kidney Neoplasms.

Is NCT01117779 still recruiting?

NCT01117779 is currently terminated. Last updated 19 January 2024.

Are results published for NCT01117779?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-01-19 · How we verify

NCT01117779: TRACE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Tracking Renal Tumors After Cryoablation Evaluation

Terminated Results posted Last updated 19 January 2024

What this trial tests

trial testing Cryoablation in Kidney Neoplasms in 246 participants. Terminated before completion.

Timeline

9 July 2010

Primary endpoint
24 November 2020

24 November 2020

Quick facts

Lead sponsor	Boston Scientific Corporation
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	246
Start date	9 July 2010
Primary completion	24 November 2020
Estimated completion	24 November 2020
Sites	7 locations across United States

Drugs / interventions tested

Cryoablation — full drug profile →

Conditions studied

Kidney Neoplasms — all drugs for Kidney Neoplasms →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

18 and older, any sex, with Kidney Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes in Lesion Size Primary · Baseline and months 6, 12, 24, 36, 48 and 60

Changes to lesion size using greatest trans-axial diameter (cm) from baseline through the follow-up intervals.

Baseline

Group	Value	95% CI
Cryoablation	2.5	2.0 – 3.1

Month 6

Group	Value	95% CI
Cryoablation	-0.2	-0.7 – 0.4

Month 12

Group	Value	95% CI
Cryoablation	-0.4	-0.9 – -0.1

Month 24

Group	Value	95% CI
Cryoablation	-0.8	-1.6 – -0.2

Month 36

Group	Value	95% CI
Cryoablation	-1.0	-1.8 – -0.5

Month 48

Group	Value	95% CI
Cryoablation	-1.0	-1.7 – -0.4

Month 60

Group	Value	95% CI
Cryoablation	-1.0	-1.8 – -0.4

Renal Function Status Primary · Baseline and months 6, 12, 24, 36, 48 and 60

Determined by the estimated Median Glomerular Filtration Rate (eGFR) measure using mL/min

Baseline

Group	Value	95% CI
Cryoablation	64.9	50.6 – 81.8

Month 6

Group	Value	95% CI
Cryoablation	60.3	48.3 – 78.3

Month 12

Group	Value	95% CI
Cryoablation	59.75	47.5 – 73.7

Month 24

Group	Value	95% CI
Cryoablation	59.72	42.3 – 75.3

Month 36

Group	Value	95% CI
Cryoablation	57.51	43.3 – 73.4

Month 48

Group	Value	95% CI
Cryoablation	59.50	47.0 – 70.5

Month 60

Group	Value	95% CI
Cryoablation	60.00	43.9 – 74.5

Hospital Stay Primary · Average duration of 2 days or longer

Length of time in hospital is the duration of the patient's in-hospital time measured in hours, from intervention to discharge with the average duration of hospitalization being 2 days but could be much longer.

Group	Value	95% CI
Cryoablation	29.3	25.8 – 34.1

Post-cryoablation Lesion Recurrence With Enhancement Primary · Months 6, 12, 24, 36, 48 and 60

Lesions with imaging that showed contrast enhancement based on investigator assessment.

Month 6

Group	Value	95% CI
Cryoablation	4

Month 12

Group	Value	95% CI
Cryoablation	3

Month 24

Group	Value	95% CI
Cryoablation	4

Month 36

Group	Value	95% CI
Cryoablation	1

Month 48

Group	Value	95% CI
Cryoablation	4

Month 60

Group	Value	95% CI
Cryoablation	1

Disease-specific Survival Rates Primary · Month 60

Disease-specific survival rate is the time in days from cryoprocedure to death due to kidney cancer. Subjects who are alive will be censored at date of their last visit. Subjects who have died from causes other than kidney cancer will be censored at the time of death. Patients are followed up for duration of registry which is 5 years.

Group	Value	95% CI
Cryoablation	221
Cryoablation	25

Overall Survival Rates Primary · Month 60

Death due to any cause

Group	Value	95% CI
Cryoablation	25
Cryoablation	221

Quality of Life Assessment Primary · Months 6 and 12

QoL SF12 is a health status survey to monitor outcomes in general and specific populations. Scoring system for the SF12 is norm-based scoring (NBS). This rescaling is done by linear transformation.The scale for each component is provided where the min = worst health and max= best health. Scale range (min-max,range): GH 23.9-63.7,39.8; PF 25.6-57.1,31.5 ; RP 23.6-57.5, 33.9; BP 21.7-57.7,36.1; VT 29.4-68.7, 39.4; SF 21.3-56.9,35.6; RE 14.7-56.3,41.6; HM 18.3-64.2,45.9; PCS 9.9-76,66 MCS 3.2-77.9,74.7

General Health at month 6

Group	Value	95% CI
Cryoablation	47.750	33.84 – 57.69

General Health at month 12

Group	Value	95% CI
Cryoablation	47.750	33.84 – 57.69

Physical Functioning at month 6

Group	Value	95% CI
Cryoablation	41.320	33.45 – 57.06

Physical Functioning at month 12

Group	Value	95% CI
Cryoablation	49.190	41.32 – 57.06

Role Physical at month 6

Group	Value	95% CI
Cryoablation	44.770	40.54 – 57.46

Role Physical at month 12

Group	Value	95% CI
Cryoablation	49.000	40.54 – 57.46

Bodily Pain at month 6

Group	Value	95% CI
Cryoablation	48.710	39.69 – 57.73

Bodily Pain at month 12

Group	Value	95% CI
Cryoablation	48.710	39.69 – 57.73

Development of Metastatic Disease. Primary · Month 60

Time between cryotherapy and first evidence of metastatic disease

Group	Value	95% CI
Cryoablation	18.7	10 – 44.8

Total Number of Recurrences Primary · Month 60

Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation).

Group	Value	95% CI
Cryoablation	18

Procedure Method Outcomes Secondary · During the procedure and immediately after it, an average of 2 hours.

An assessment of outcomes across laparoscopic-assisted, percutaneous and open cryoablation procedures.

Procedure Method: Laparoscopic

Group	Value	95% CI
INTENT TO TREAT (ITT)- POPULATION	99
RENAL CELL CARCINOMA (RCC) POPULATION	63

Procedure Method: Percutaneous

Group	Value	95% CI
INTENT TO TREAT (ITT)- POPULATION	146
RENAL CELL CARCINOMA (RCC) POPULATION	81

Procedure Method: Open

Group	Value	95% CI
INTENT TO TREAT (ITT)- POPULATION	1
RENAL CELL CARCINOMA (RCC) POPULATION	1

Number of lesions treated with cryoablation is One

Group	Value	95% CI
INTENT TO TREAT (ITT)- POPULATION	242
RENAL CELL CARCINOMA (RCC) POPULATION	144

Number of lesions treated with cryoablation is Two

Group	Value	95% CI
INTENT TO TREAT (ITT)- POPULATION	2
RENAL CELL CARCINOMA (RCC) POPULATION	1

Number of lesions treated with cryoablation is Three

Group	Value	95% CI
INTENT TO TREAT (ITT)- POPULATION	2
RENAL CELL CARCINOMA (RCC) POPULATION	0

Type of hemostatic agents or maneuvers used is None

Group	Value	95% CI
INTENT TO TREAT (ITT)- POPULATION	154
RENAL CELL CARCINOMA (RCC) POPULATION	85

Type of hemostatic agents or maneuvers used=Compression

Group	Value	95% CI
INTENT TO TREAT (ITT)- POPULATION	6
RENAL CELL CARCINOMA (RCC) POPULATION	3

Standard of Care Follow-up Procedures Secondary · These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure

Characterization of standards of care for cryoablation procedure follow-up across the participating registry centers.

Disease free=Yes

Group	Value	95% CI
ITT Population	114
RCC Population	61

Disease free=No

Group	Value	95% CI
ITT Population	8
RCC Population	7

Disease free=Indeterminate

Group	Value	95% CI
ITT Population	2
RCC Population	2

New therapies for renal cancer (patient specific)=Yes

Group	Value	95% CI
ITT Population	4
RCC Population	4

New therapies for renal cancer (patient specific)=Yes [Local]

Group	Value	95% CI
ITT Population	4
RCC Population	4

New therapies for renal cancer (patient specific)=Yes [Systemic]

Group	Value	95% CI
ITT Population	0
RCC Population	0

New thereapies for renal cancer (patient specific)=No

Group	Value	95% CI
ITT Population	121
RCC Population	67

Adverse events — posted to ClinicalTrials.gov

Time frame: Median follow-up of 60.1 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Kidney Lesions Amenable to Cryoablation [ITT Population]

Serious: 11/246 (4%)

Deaths: 26/246

Serious adverse events (9 terms)

Reaction	System	Kidney Lesions Amenable to…
BLEEDING/HEMORRHAGE, GU	Surgical and medical procedures	—
OTHER	General disorders	—
ARRHYTHMIA-SUPRAVENTRICULAR	Cardiac disorders	—
HEMATOMA	Surgical and medical procedures	—
INFECTION (DOCUMENTED CLINICALLY) WITH GRADE 3 OR 4 ANC	General disorders	—
PAIN	General disorders	—
PLEURAL EFFUSION (NON-MALIGNANT)	Respiratory, thoracic and mediastinal disorders	—
RENAL HEMORRHAGE	Renal and urinary disorders	—
STRICTURE OF THE COLLECTION SYSTEM OR URETERS/STRICTURE/STENOSIS	Renal and urinary disorders	—

Other adverse events (13 terms — click to expand)

Reaction	System	Kidney Lesions Amenable to…
OTHER	General disorders	—
PAIN	General disorders	—
HEMATOMA	Surgical and medical procedures	—
CREATININE ELEVATION	Renal and urinary disorders	—
URINARY RETENTION/OLIGURIA	Renal and urinary disorders	—
BLEEDING/HEMORRHAGE, GU	Renal and urinary disorders	—
VOMITING	General disorders	—
ARRHYTHMIA-SUPRAVENTRICULAR	Cardiac disorders	—
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	—
BLEEDING/HEMORRHAGE, GI	Gastrointestinal disorders	—
HYPERTENSION	Vascular disorders	—
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	—
RENAL HEMORRHAGE	Renal and urinary disorders	—

Most-reported serious reactions: BLEEDING/HEMORRHAGE, GU, OTHER, ARRHYTHMIA-SUPRAVENTRICULAR, HEMATOMA, INFECTION (DOCUMENTED CLINICALLY) WITH GRADE 3 OR 4 ANC, PAIN, PLEURAL EFFUSION (NON-MALIGNANT), RENAL HEMORRHAGE.

Data from ClinicalTrials.gov NCT01117779 adverse events section.

Sponsor's own description

TRACE is an observational, open-label, single-arm, multi-center registry of subjects who have undergone renal lesion cryoablation per their physician's standard of care. Patients 18 years of age or older who have been determined to be an appropriate candidate for cryoablation will be offered enrollment into the registry. Subjects will be observed for five years from the date of their cryoablation procedure.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Cryoablation

Trials testing the same drug.

NCT07380789 — Comprehensive Multicenter Study on the Management of Acute Pain Following Thoracic Combat-Related Trauma in Ukraine · NA · recruiting
NCT07306286 — Cryoablation Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-L · Phase 2 · recruiting
NCT07147088 — Cryoablation Combined With SHR-1701 Plus Famitinib in Patients With Advanced Intrahepatic Cholangiocarcinoma. · Phase 2 · not yet recruiting
NCT06991231 — The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty · NA · recruiting
NCT06848881 — Cryoablation vs Thoracoscopic Surgery for GGN · NA · recruiting

Other recruiting trials for Kidney Neoplasms

Currently open trials in the same condition.

NCT06676527 — Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma · recruiting
NCT06536439 — Planning Operative Strategy Using a Digital Renal Artery Clamping Tool · NA · recruiting
NCT06715878 — Zero Ischemia Robot-Assisted MWA Assisted Suture-less Tumor Enucleation of RCC With T1 Stage · NA · recruiting
NCT05218811 — Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach · NA · recruiting
NCT06126159 — MRI Functional Imaging Characteristics and Fat Quantification of CT-fat-free Renal Neoplasms: Relationships With Histolo · NA · active not recruiting

Other Boston Scientific Corporation trials

Trials by the same sponsor.

NCT07458243 — Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT · not yet recruiting
NCT07458217 — Combined CM and STN Stimulation for Motor Epilepsy · NA · not yet recruiting
NCT07276815 — OverStitch NXT Endoscopic Suture System · NA · not yet recruiting
NCT07353710 — A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure · NA · not yet recruiting
NCT07195708 — Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365') · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01117779 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Scientific Corporation
Last refreshed: 19 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01117779.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01117779: TRACE

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (9 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Cryoablation

Other recruiting trials for Kidney Neoplasms

Other Boston Scientific Corporation trials

Verify against primary sources