Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy

March 13, 2024 updated by: Nanfang Hospital, Southern Medical University

A Prospective Cohort Study of Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy

Immune checkpoint inhibitors have ushered in a new era of cancer treatment, bringing significant survival benefits to patients. However, some patients have accelerated tumor growth in the early stage of immunotherapy, called hyperprogression. The quality of life of patients with hyperprogression is seriously reduced, and there is no effective treatment at present, and the prognosis is extremely poor. Therefore, early identification of high-risk groups of hyperprogression is the key to prevent hyperprogression. However, there are no effective biomarkers to predict hyperprogression. By sequencing, proteomics and metabolomics analysis of clinical tissue and blood samples, we found that the level of SAA1 was significantly increased in patients with hyperprogression, and SAA1 was an effective marker for predicting hyperprogression in pan-cancer. We planned to conduct a multicenter, prospective cohort study to verify the reliability of SAA1 as a marker for predicting hyperprogression of immunotherapy in pan-cancer patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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.
374

Contacts and Locations

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

Study Locations

  • China
      • Fuzhou, China
        • Not yet recruiting
        • Fujian Provinical Hospital
        • Contact:
          • Yongmei Dai
      • Huizhou, China
        • Not yet recruiting
        • Huizhou Central People's Hospital
        • Contact:
          • Yunming Tian
      • Jieyang, China
        • Not yet recruiting
        • Jieyang People's Hospital
        • Contact:
          • Peibao Lai
      • Meizhou, China
        • Not yet recruiting
        • Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
        • Contact:
          • Jianda Sun
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
        • Principal Investigator:
          • Jian Guan, M.D.

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

Probability Sample

Study Population

Cancer patients who need to accept immunotherapy

Description

Inclusion Criteria:

  1. Over 18 years of age
  2. Voluntarily sign informed consent
  3. The pathological diagnosis was nasopharyngeal carcinoma, head and neck tumor, lung cancer, breast cancer, stomach cancer, colorectal cancer, glioma, esophageal cancer, liver cancer, bile duct cancer, cervical cancer, prostate cancer, bladder cancer and other malignant tumors
  4. Need to be treated with immune checkpoint inhibitors
  5. ECOG PS Score: 0/1.

Exclusion Criteria:

  1. There are contraindications to immunotherapy
  2. Combined with other tumors (basal cell or squamous cell skin cancer that has been cured, and cervical cancer in situ removed) External)
  3. Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor disease status, uncontrolled diabetes (fasting blood glucose > 1.5 × ULN), and mental illness.
  4. At the investigator's discretion, those who was not considered to be suitable for participation in the study.

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
Incidence of hyperprogression
Time Frame: 2 years
Incidence of hyperprogression will be calculated.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Event-free survival
Time Frame: 3 years
Event-free survival was defined as the time from the date of inclusion until hyperprogression or death from any cause.
3 years
Progression-free survival
Time Frame: 3 years
Progression-free survival was defined as the time from the date of inclusion until disease progress or death from any cause.
3 years
Overall survival
Time Frame: 3 years
Overall survival was defined as the time from the date of inclusion until death from any cause.
3 years

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.
Nanfang Hospital, Southern Medical University

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 (Actual)

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.
February 18, 2024

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.
December 31, 2025

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.
October 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 18, 2024

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 18, 2024

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.
February 23, 2024

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 15, 2024

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.
March 13, 2024

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.
March 1, 2024

More Information

Terms related to this study

Keywords

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.
  • NFEC-2024-067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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