Tumor Immunity and Cancer Recurrence Prediction Model

February 27, 2025 updated by: Anhui Provincial Hospital

The purpose of this observational study is to understand the predictive effect of the laboratory-developed TIMES scoring system on the recurrence status of cancer patients who have undergone surgical tumor resection. The main questions it aims to answer are:

Can the TIMES scoring system accurately predict the recurrence status of cancer patients who have undergone surgical tumor resection? What is the accuracy of the TIMES scoring system? The medical records or biological specimens used in this study were obtained from previous clinical treatments, and the tissues used were collected from post-surgical discarded tissues from the participants, which will not affect their health. Researchers will continuously monitor the disease progression of the participants for up to 10 years or until cancer recurrence occurs.

Study Overview

Status

Not yet recruiting

Conditions

Cancer

Detailed Description

No grouping, the long-term tracking of participants' disease progression and recurrence status will be compared with the analysis results of the collected discarded tumor tissues from the participants' surgeries

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Cheng Sun
Phone Number: +86 13956074139
Email: charless@ustc.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Participants must be at least 18 years old, not pregnant, and not breastfeeding, diagnosed with cancer (such as liver cancer, lung cancer, gastric cancer, colorectal cancer, etc.), and eligible for surgical resection

Description

Inclusion Criteria：

1.Adult males and females (non-pregnant, non-lactating)； 2.18 years or older (inclusive); 3.Diagnosis: Diagnosed with cancer (e.g., liver cancer, lung cancer, gastric cancer, colorectal cancer, etc.) and eligible for surgical resection; 4.Informed Consent: Participants must be fully informed about the study prior to participation and voluntarily sign a written informed consent form;

Exclusion Criteria：

Specimens from pregnant or lactating patients will not be included in this study, and participant should have no plans for pregnancy or lactation within the next 2 years.
Participants must be at least 18 years old.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence Time Frame: From the date of random grouping to the date of first recorded recurrence or death due to any reason, whichever comes first, the evaluation lasts up to 120 months.	The time from when the participant undergoes surgical treatment to the recurrence of cancer, which is obtained by researchers through phone follow-ups.	From the date of random grouping to the date of first recorded recurrence or death due to any reason, whichever comes first, the evaluation lasts up to 120 months.
disease-free progression period Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months	The time from when the participant undergoes surgical treatment to any progression of cancer, which is obtained by researchers through phone follow-ups.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
RECIST1.1 Time Frame: From the start of clinical treatment to the end of clinical treatment, up to a maximum of 120 months.	Tumor size: Measure the longest diameter or maximum cross-sectional area of the target tumor and record its changes. Evaluation criteria: Complete Response (CR): All target lesions disappear. Partial Response (PR): The tumor's maximum diameter or volume decreases by at least 30%. Stable Disease (SD): The tumor shows no significant growth or shrinkage, with changes within a certain range. Progressive Disease (PD): The tumor's maximum diameter or volume increases by at least 20%.	From the start of clinical treatment to the end of clinical treatment, up to a maximum of 120 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 23, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)