NCT05917106

Brief Summary

To conduct prospective studies to confirm the value of circulating tumor DNA and its abnormal methylation in longitudinal monitoring of patients undergoing kidney cancer surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Dec 2022

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

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Study Timeline

Key milestones and dates

Study Progress45%
Dec 2022Jun 2030

Study Start

First participant enrolled

December 26, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

5.4 years

First QC Date

June 9, 2023

Last Update Submit

December 4, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • To explore the predictive effect of ctDNA methylomics on the prognosis and medication guidance of renal carcinoma.

    5 years

  • To explore the advance time of ctDNA methylomics in monitoring postoperative recurrence of renal cancer compared with imaging.

    5 years

  • The molecular mechanism of renal cancer recurrence was analyzed with baseline tissue and circulating methylation profiles.

    5 years

  • A renal cancer recurrence risk model was established based on clinical information, molecular risk factors and ctDNA methylomics

    5 years

Eligibility Criteria

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

RCC patients undergoing surgical treatment

You may qualify if:

  • Newly diagnosed renal cell carcinoma
  • Without any treatment
  • Agree and accept radical surgical treatment
  • Signed written informed consent
  • ECOG(Eastern Cooperative Oncology Group) performance is 0 or 1
  • Follow up protocol and related procedures

You may not qualify if:

  • Had other cancers
  • Had received any antitumor therapy before
  • Known or suspected active autoimmune disease
  • Informed consent is not possible due to medical or psychiatric problems
  • Have clinical symptoms or diseases of the heart that are not well controlled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China

Nanjing, Jiangsu, 210000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fresh tumor tissue and blood samplesare collected from each patient.Blood collection time: P0: within 7 days before surgery P1:3-7 days after surgery PF1:1 month postoperatively PF2: 4months postoperatively PF3:sequentially 3 months apart PA1: Before postoperative adjuvant therapy PA2: During postoperative adjuvant therapy PA3: After postoperative adjuvant therapy PA4:sequentially spaced 3 months PR: detection when recurrence

MeSH Terms

Conditions

CarcinomaCarcinoma, Renal CellKidney Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief urologist

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 23, 2023

Study Start

December 26, 2022

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2030

Last Updated

December 11, 2025

Record last verified: 2025-12

Locations