NCT03358628

Brief Summary

By obtaining clinical specimens from participants with high-grade bone and soft tissue sarcomas to establish and profile as freshly implanted tumors in mice, the aim of this study is to identify agents with predicted activity in the host patient while also potentially providing them with individualized cancer treatment options

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

November 25, 2017

Last Update Submit

November 29, 2017

Conditions

Osteosarcoma

Keywords

OsteosarcomaPatient-derived xenograft

Outcome Measures

Primary Outcomes (1)

  • Measure of drug sensitive PDX to a panel of drugs as a predictor of clinical response in matched host

    Sensitivity measured by tumor growth inhibition (\>80%) or objective tumor response (regression) as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

    up to 2 years

Study Arms (1)

Osteosarcoma

Osteosarcoma patients with metastatic relapsed or unresectable progressive disease (total n= up to 20) following resection of the primary lesion and adjuvant chemotherapy.

Other: Molecular Profiling & In Vivo drug testing in PDX

Interventions

Molecular Profiling & In Vivo drug testing in PDXOTHER

Molecular profiling of host tumour sample and PDX will be performed and analyzed by an expert panel. In vitro drug testing using organoid culture generation may also be performed if sufficient fresh tissue is available. Matched treatment recommendation based on profiling and in vivo PDX drug testing results will be made, if available.

Osteosarcoma

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with high-grade osteosarcoma referred to, or being treated at Peking University People's Hostpital.

You may qualify if:

  • Age \>18 years;
  • Diagnosis confirmed histologically and reviewed centrally;
  • Prior treatment (completed \>4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
  • Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy \>3 months;
  • Adequate renal, hepatic, and hemopoietic function;
  • Normal or controlled blood pressure;
  • Surgery and/or radiotherapy completion at least 1 month before enrollment.

You may not qualify if:

  • Central nervous system metastasis;
  • Have had other kinds of malignant tumors at the same time;
  • Cardiac insufficiency or arrhythmia;
  • Uncontrolled complications, such as diabetes mellitus and so on;
  • Coagulation disorders;
  • Urine protein≄ ++;
  • Pleural or peritoneal effusion that needs to be handled by surgical treatment;
  • Combined with other infections or wounds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, formalin fixed paraffin embedded blocks, or fresh tumor tissue

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Study Officials

  • Wei Guo, MD, PhD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingting Ren, PhD

CONTACT

86-10-88324470tumorcenter@163.com

Yidan Zhang, MD

CONTACT

86-13810330739zhangyidan@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Musculoskeltal Tumor Center

Study Record Dates

First Submitted

November 25, 2017

First Posted

November 30, 2017

Study Start

February 1, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2025

Last Updated

November 30, 2017

Record last verified: 2017-11