the Exploration of MTAP Deletion in Osteosarcoma by Immunohistochemistry

NCT07593573 | Active Not Recruiting DMC

• 1 other identifier: PKUPH-sarcoma 23
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

MTAP deletion frequently occurs in osteosarcoma, and PRMT5 has been identified as a synthetic lethal target for cancers with homozygous deletion of the MTAP gene, making it a promising target for anti-tumor drug development.This study aims to evaluate the overall status of MTAP deficiency in the tissues of osteosarcoma patients and its correlation with clinical features such as metastasis and immune subtypes by examining the MTAP protein expression levels in previous histological samples of the patients and combining this with their clinicopathological data.

Conditions

Osteosarcoma; MTAP Deletion; Immunohistochemistry

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  from the start of target treatment until disease progression or death, whichever came first.

  2 years

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Initial treated osteosarcoma patients in PKUPH and later would recieve definitive surgery in PKUPH with complete clinical materials.

You may qualify if:

• advanced recurrent and refractory osteosarcoma confirmed by histopathology;
• initial treatment in the Orthopedic/Oncology Departments of Peking University People's Hospital or Peking University Shougang Hospital;
• progression less than 6 months after first-line chemotherapy with a combination of high-dose methotrexate, doxorubicin, cisplatin and ifosfamide (first-line chemotherapy);
• measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1) ;
• Eastern Cooperative Oncology Group performance status ≤ 1 ;
• acceptable haematologic, hepatic, and renal function.

You may not qualify if:

• those who had been previously treated with antiangiogenic TKIs and single IE chemotherapy;
• those who had severe or uncontrolled medical disorders that could jeopardize the outcomes of the study. These confounding conditions included, cardiac clinical symptoms or disease with left ventricular ejection fraction\<50%, and hypertension that could not be well controlled with antihypertensive drugs.;
• all patients were assessed by the sarcoma board including a thoracic surgeon with at least 10 years surgical experience. Patients with lung metastases only were carefully assessed for eligibility for metastasectomy, of whom those who were suitable for surgery were excluded from this study;
• weight loss of 20% or more before illness;
• brain or leptomeningeal metastasis;
• surgical procedure or radiotherapy within 4 weeks of enrollment;
• activegastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation;
• proteinuria or hematuria, denutrition with albuminemia \<25 g/L;
• women who were pregnant or breast feeding, other malignancy;
• positive HBV/HCV/HIV serology, and known allergy to the experimental agents.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Sailan(Hangzhou)Biopharmaceutical Technology Co.,Ltd.: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Osteosarcoma tissue

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician, associate professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start: December 15, 2025
• Primary Completion: June 15, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: May 18, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)