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

NCT06276088 | Recruiting

• 1 other identifier: NFEC-2024-067
• Study Type: observational
• Target: 374
• Locations: 1 country
• Sites: 5

Brief Summary

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

Immunotherapy; Hyperprogression; Biomarker

Keywords

SAA1; Immunotherapy; Hyperprogression; Pan-cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of hyperprogression

  Incidence of hyperprogression will be calculated.

  2 years

Secondary Outcomes (3)

• Event-free survival

  3 years

• Progression-free survival

  3 years

• Overall survival

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cancer patients who need to accept immunotherapy

You may qualify if:

• Over 18 years of age
• Voluntarily sign informed consent
• 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
• Need to be treated with immune checkpoint inhibitors
• ECOG PS Score: 0/1.

You may not qualify if:

• There are contraindications to immunotherapy
• Combined with other tumors (basal cell or squamous cell skin cancer that has been cured, and cervical cancer in situ removed) External)
• 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.
• At the investigator's discretion, those who was not considered to be suitable for participation in the study.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (5)

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, 510515, China

RECRUITING

Fujian Provinical Hospital

Fuzhou, China

NOT YET RECRUITING

Huizhou Central People's Hospital

Huizhou, China

NOT YET RECRUITING

Jieyang people's hospital

Jieyang, China

NOT YET RECRUITING

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

Meizhou, China

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and plasma

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 23, 2024
• Study Start: February 18, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)