Tumor Immunity and Cancer Recurrence Prediction Model

NCT06855290 | Not Yet Recruiting

• 1 other identifier: KY2021204
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cancer

Keywords

cancer; immunity; tumor

Outcome Measures

Primary Outcomes (3)

• recurrence

  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

  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

  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.

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

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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Surgical resection of tumor tissue samples (The tumor tissue will not be used for DNA extraction).

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Cheng Sun

CONTACT

+86 13956074139; charless@ustc.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 3, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 3, 2025

Record last verified: 2025-02