Actively Recruiting

Age: 18Years +
All Genders
NCT06276088

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

Led by Nanfang Hospital, Southern Medical University · Updated on 2024-03-15

374

Participants Needed

5

Research Sites

140 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 18 years of age
  • Voluntarily sign informed consent
  • Pathological diagnosis of 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, or other malignant tumors
  • Need to be treated with immune checkpoint inhibitors
  • ECOG performance status score of 0 or 1
Not Eligible

You will not qualify if you...

  • Contraindications to immunotherapy
  • Presence of other tumors (except cured basal cell or squamous cell skin cancer, or cervical cancer in situ removed)
  • Serious coexisting medical conditions that pose unacceptable risk or affect trial adherence, such as unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor disease status, uncontrolled diabetes (fasting blood glucose > 1.5 times upper limit of normal), or mental illness
  • Considered unsuitable for participation by the investigator

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, China, 510515

Actively Recruiting

2

Fujian Provinical Hospital

Fuzhou, China

Not Yet Recruiting

3

Huizhou Central People's Hospital

Huizhou, China

Not Yet Recruiting

4

Jieyang people's hospital

Jieyang, China

Not Yet Recruiting

5

Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou

Meizhou, China

Not Yet Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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