Precision Therapy Based on Immune Microenvironment by Transcriptome Sequencing of Osteosarcoma, a Prospective, Multi-cohort Exploratory Clinical Study (PTMTO)

Peking University

Status: Not yet enrolling

Conditions: Osteosarcoma; Tumor Microenvironment; Transcriptome; Precision Medicine

Treatments: Drug: Chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06776198

PKUPH-sarcoma 21

Details and patient eligibility

About

Bagaev et al. have identified four tumor microenvironment (TME) subtypes that are conserved across diverse cancers and correlated with immunotherapy response in melanoma, bladder, and gastric cancers. They provided a visual tool revealing the TME subtypes integrated with targetable genomic alterations, which provided a planetary view of each tumor that can aid in oncology clinical decision making. We aim to use this tool to prospectively analyse the biopsy specimens of osteosarcomas to identify their TME subtypes so as to deliver appropriate treatment strategy if these osteosarcomas experience disease progression afterwards. We will compare the past sequencing date stored in PKUPH bank so as to compare the event-free survival(EFS) of these patients to check the Superiority of this method later.

Enrollment: 100 estimated patients

Sex: All

Ages: 8 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (i) patients who have been suspected for osteosarcoma with enough clinical or radiographic information;
• (ii) patients who have evaluable lesions to resect or follow;
• (iii) patients who are planned to be operate with enough flesh specimens for this study.

Exclusion criteria

• (i) clinical information was not complete;
• (ii) lost to follow-up.

Trial design

100 participants in 4 patient groups

Immune-Enriched, Fibrotic Group (IE/F)

Treatment:

Drug: Chemotherapy

Immune-Enriched, Non-Fibrotic Group (IE)

Treatment:

Drug: Chemotherapy

Fibrotic Group (F)

Treatment:

Drug: Chemotherapy

Depleted Group (D)

Treatment:

Drug: Chemotherapy