NCT03414827

Brief Summary

Recruitment of participants to the study takes place at the urological department at Zealand University Hospital, Roskilde, Feb. 2018-April 2018. 10 people with diagnosis of renal cancer should be recruited in phases 1. Subsequently, biological materials from 100 patients with kidney cancer will be used from the national Biobank. In phase 3, 10 patients will be recruited for the final gene test.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress84%
Feb 2019Dec 2027

First Submitted

Initial submission to the registry

January 13, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

6.8 years

First QC Date

January 13, 2018

Last Update Submit

January 27, 2024

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (1)

  • DNA

    Sequence variation in specific genes

    30 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* Patients who have been diagnosed with kidney cancer and found suitable for inclusion will be included in the project. * The biological material has been collected during routine treatment. * Biological material has not been collected in connection with a previous study.

You may qualify if:

  • Patients who have been diagnosed with kidney cancer.

You may not qualify if:

  • Patients without signs of malignancy at final histology report.
  • Incapacitated patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

RECRUITING

Related Publications (1)

  • Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.

    PMID: 32203306DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood, urine

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 13, 2018

First Posted

January 30, 2018

Study Start

February 1, 2019

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2027

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

DK(1)