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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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：

  1. 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.
  2. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2021204

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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