protocolSection identificationModule nctId: NCT06276088, orgStudyIdInfo id: NFEC-2024-067, briefTitle: Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Immunotherapy, conditions: Hyperprogression, conditions: Biomarker, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 374, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of hyperprogression, secondaryOutcomes measure: Event-free survival, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang hospital, Southern medical university, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Jian Guan, M.D., role: CONTACT, phone: 86+13632102247, email: guanjian5461@163.com, contacts name: Jian Guan, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Fujian Provinical Hospital, status: NOT_YET_RECRUITING, city: Fuzhou, country: China, contacts name: Yongmei Dai, role: CONTACT, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Huizhou Central People's Hospital, status: NOT_YET_RECRUITING, city: Huizhou, country: China, contacts name: Yunming Tian, role: CONTACT, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Jieyang people's hospital, status: NOT_YET_RECRUITING, city: Jieyang, country: China, contacts name: Peibao Lai, role: CONTACT, geoPoint lat: 23.5418, lon: 116.36581, locations facility: Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou, status: NOT_YET_RECRUITING, city: Meizhou, country: China, contacts name: Jianda Sun, role: CONTACT, geoPoint lat: 24.2886, lon: 116.11767, hasResults: False