A Multimodal Predictive Recurrence Score for Patients With Clear Cell Renal Cell Carcinoma

NCT06656039 | Completed DMC

• 1 other identifier: ccRCC MRPS
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this observational study is to construct a predictive recurrence model for renal clear cell carcinoma through an artificial intelligence multimodal algorithm, which will improve the prognosis and survival time of ccRCC patients by helping clinicians to formulate individualised follow-up and to screen for appropriate adjuvant therapy candidates.

Conditions

Renal Cell Carcinoma, Clear Cell

Keywords

Renal Cell Carcinoma; Multimodal; Artificial Intelligence; Prognosis; Deep Learning; Multicentre Study

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  Defined as from surgery to tumor recurrence or follow-up deadline

  "Baseline, immediately after the surgery", "Tumour recurrence or further follow-up", "Three months after surgery", "Six months after surgery", "Every year after surgery, at least follow-up 2years, up to 10 years"

Study Arms (3)

Training cohort

Validation cohort

Test cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pathologically confirmed postoperative patients with renal clear cell carcinoma of TNM stage I-III

You may qualify if:

• Patients with malignant renal tumours must have postoperative pathological confirmation of renal clear cell carcinoma with pathological TNM stage Ⅰ-Ⅲ;
• Have available preoperative imaging
• Have available post-operative pathological paraffin samples or HE-stained tissue sections
• Must agree to and be able to comply with the study's visit schedule and other requirements as specified in the protocol, including follow-up visits by telephone

You may not qualify if:

• The patient's tumour type cannot be determined on the basis of histopathological sections
• Simultaneous combination of primary tumours at other sites;
• No regular follow-up imaging data
• Cases in which other factors led the investigator to believe that enrolment was inappropriate

Sponsors & Collaborators

• RenJi Hospital: lead
• The First Affiliated Hospital of Anhui Medical University: collaborator
• The Fourth Affiliated Hospital of Harbin Medical University: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• Qianfoshan Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

HE pathology sections of ccRCC postoperative tissues

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 24, 2024
• Study Start: January 1, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)