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

NCT06776198 | Not Yet Recruiting

• 1 other identifier: PKUPH-sarcoma 21
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteosarcoma; Transcriptome; Tumor Microenvironment; Precision Medicine

Keywords

osteosarcoma; transcriptome; tumor microenviroment; precision medicine

Outcome Measures

Primary Outcomes (1)

• Event-free Survival (EFS)

  From biopsy to progression/last follow-up

  2 year

Secondary Outcomes (1)

• Event-free Survival (EFS) for the second time

  2 year

Other Outcomes (1)

• Correlation with some DNA target expression

  1 year

Study Arms (4)

Immune-Enriched, Fibrotic Group (IE/F)

Drug: Chemotherapy

Immune-Enriched, Non-Fibrotic Group (IE)

Drug: Chemotherapy

Fibrotic Group (F)

Drug: Chemotherapy

Depleted Group (D)

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

Group IE/F: After progression, try LRRC15 ADC + PD-1 inhibitors; Group IE: After progression, try simple anti-PD-1 inhibitors; Group F: After progression, try LRRC15 ADC; Group D: After progression, try B7-H3 ADC or other irrinotecan analogue

Depleted Group (D); Fibrotic Group (F); Immune-Enriched, Fibrotic Group (IE/F); Immune-Enriched, Non-Fibrotic Group (IE)

Eligibility Criteria

• Age: 8 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Initially treated osteosarcoma

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Related Publications (1)

• Bagaev A, Kotlov N, Nomie K, Svekolkin V, Gafurov A, Isaeva O, Osokin N, Kozlov I, Frenkel F, Gancharova O, Almog N, Tsiper M, Ataullakhanov R, Fowler N. Conserved pan-cancer microenvironment subtypes predict response to immunotherapy. Cancer Cell. 2021 Jun 14;39(6):845-865.e7. doi: 10.1016/j.ccell.2021.04.014. Epub 2021 May 20.

  PMID: 34019806 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Wholeexome sequencing (WES) and RNA sequencing (RNA-seq)

MeSH Terms

Conditions

Osteosarcoma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Lu Musculoskeletal Tumor Center of PKUPH, M.D.

CONTACT

+86-86491437; xielu@pkuph.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 100 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Musculoskeletal Tumor Center

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share