CancerNCT06855290
Tumor Immunity and Cancer Recurrence Prediction Model
An observational study of Cancer, run by Anhui Provincial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Conditions
- Cancer
- Keywords
- cancer, immunity, tumor
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
The time from when the participant undergoes surgical treatment to the recurrence of cancer, which is obtained by researchers through phone follow-ups.
Measured: 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.
Measured: 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%.
Measured: From the start of clinical treatment to the end of clinical treatment, up to a maximum of 120 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855290
- Sponsor's protocol ID
- KY2021204
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Immunity and Cancer Recurrence Prediction Model
- ClinicalTrials.gov ID
- NCT06855290
- Acronym / sponsor ID
- KY2021204
- Conditions
- Cancer
- Keywords
- cancer, immunity, tumor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Anhui Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheng Sun (+86 13956074139, charless@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.