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Trial Title:
Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy
NCT ID:
NCT06276088
Condition:
Immunotherapy
Hyperprogression
Biomarker
Conditions: Keywords:
SAA1
Immunotherapy
Hyperprogression
Pan-cancer
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Cancer patients who need to accept immunotherapy
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanfang hospital, Southern medical university
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Guan, M.D.
Phone:
86+13632102247
Email:
guanjian5461@163.com
Investigator:
Last name:
Jian Guan, M.D.
Email:
Principal Investigator
Facility:
Name:
Fujian Provinical Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yongmei Dai
Facility:
Name:
Huizhou Central People's Hospital
Address:
City:
Huizhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yunming Tian
Facility:
Name:
Jieyang people's hospital
Address:
City:
Jieyang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Peibao Lai
Facility:
Name:
Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
Address:
City:
Meizhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jianda Sun
Start date:
February 18, 2024
Completion date:
October 31, 2026
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06276088
