the Exploration of MTAP Deletion in Osteosarcoma by Immunohistochemistry

A Clinical Study on the Exploration of MTAP Deletion in Osteosarcoma Specimens by Immunohistochemistry

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteosarcoma; Immunohistochemistry; MTAP Deletion

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. those who had been previously treated with antiangiogenic TKIs and single IE chemotherapy;
2. 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.;
3. 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;
4. weight loss of 20% or more before illness;
5. brain or leptomeningeal metastasis;
6. surgical procedure or radiotherapy within 4 weeks of enrollment;
7. activegastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation;
8. proteinuria or hematuria, denutrition with albuminemia <25 g/L;
9. women who were pregnant or breast feeding, other malignancy;
10. positive HBV/HCV/HIV serology, and known allergy to the experimental agents.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	from the start of target treatment until disease progression or death, whichever came first.	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): December 14, 2026

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Osteosarcoma
• Other Study ID Numbers: PKUPH-sarcoma 23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No