NCT04506671

Brief Summary

The aim of our study is to assess the long-term oncological and functional outcomes of cryoablation for T1b renal tumors, as well as such important parameters as the patient's quality of life after treatment, and to compare the results with those after partial nephrectomy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2025

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

5 years

First QC Date

August 6, 2020

Last Update Submit

July 21, 2021

Conditions

Renal Tumor

Keywords

CryoablationRenal cancerPartial nephrectomy

Outcome Measures

Primary Outcomes (1)

  • Local recurrence

    Local recurrance will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment

    5 years

Secondary Outcomes (7)

  • Metastatic progression

    5 years

  • Quality of life assessment: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30)

    5 years

  • Renal function

    5 years

  • Rate of adverse events

    3 months

  • Blood loss

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Cryoablation group

EXPERIMENTAL

Patients with T1b renal tumor and ECOQ\>20

Procedure: Renal biopsyProcedure: Cryoablation

Partial nephrectomy group

ACTIVE COMPARATOR

Patients with T1b renal tumor

Procedure: Partial nephrectomy

Interventions

Renal biopsyPROCEDURE

Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols

Cryoablation group
CryoablationPROCEDURE

Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols

Cryoablation group
Partial nephrectomyPROCEDURE

Partial nephrectomy will be performed on the basis of the center and according to the current protocols

Partial nephrectomy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CT-confirmed renal mass \> 4 to 7 cm (T1b)

You may not qualify if:

  • Multiple renal tumors;
  • Recurrence of renal tumor;
  • Intolerance to iodine-containing contrast agents;
  • Pregnancy;
  • Patients with Bosniak 4 cysts
  • Presence of other oncological diseases;
  • Impossibility of organ-preserving treatment due to the proximity of the tumor to the vessels or the calyx-pelvic system
  • Absence of malignant pathology based on prior biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal CellKidney Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director for Research

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 10, 2020

Study Start

May 22, 2020

Primary Completion

May 22, 2025

Study Completion

June 22, 2025

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)