Clinical Evaluation for Sarcoma Originated From Bone

NCT03358992 | Unknown DMC

• 1 other identifier: CBTRA-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

Response Evaluation Criteria in Solid Tumors (RECIST) are insensitive in evaluating primary sarcoma originated from bone treated with chemotherapy or targeted therapy, which did not have the definition of measurement methods either. This study evaluates whether clinical imaging findings of sarcoma after preoperative chemotherapy correlate with tumor responses by pathological evaluation by Huvos classifications and develops reliable, quantitative, clinical response criteria.

Conditions

Sensitivity; Specificity; Histological Response; Survival

Keywords

CESOFB; clinical evaluation; RECIST; histological response; survival; osteosarcoma; Ewing sarcoma

Outcome Measures

Primary Outcomes (3)

• Sensitivity

  Sensitivity is defined as the true right clinical evaluated number/ the pathological evaluated number by different classification system.

  12 months

• Specificity

  Specificity is defined as the true wrong clincial evuluated number /the pathological evaluated number by different classification system.

  12 months

• Pathological response rate

  tumor necrosis rate descripted by Huvos

  12 months

Secondary Outcomes (2)

• progression-free survival

  24 months

• overall survival

  60 months

Eligibility Criteria

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

Study Population

Biopsy proved high-grade osteosarcoma, who could follow routine chemo-protocol for osteosarcoma, could get enrolled.

You may qualify if:

• \) histologically confirmed high-grade osteosarcoma;
• \) initially treated in Musculoskeletal Tumor Center of Peking University People's Hospital, Xijing Hospital or The Second Hospital affiliated to Zhejiang Hospital;
• \) imaging evaluation should be available;
• \) completed neo-adjuvant chemotherapy and at least 8 cycles of adjuvant chemotherapy;
• \) expected to live longer than 3 months with Eastern Cooperative Oncology Group performance status of 0 or 1;
• \) acceptable hematologic, hepatic, and renal function.

You may not qualify if:

• \) Patients who could not complete neo-adjuvant chemotherapy or at least 4-month adjuvant chemotherapy;
• \) lost to follow-up.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Xijing Hospital: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (3)

The second affliated Hospital of Zhejiang University School of medicine

Hangzhou, Zhejiang, China

RECRUITING

Musculoskeletal Tumor Center of Peking University People's Hospital

Beijing, 100044, China

RECRUITING

Xijing Hospital

Xi'an, China

RECRUITING

MeSH Terms

Conditions

Hypersensitivity; Osteosarcoma; Sarcoma, Ewing

Condition Hierarchy (Ancestors)

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

Study Officials

• Wei Guo

  Musculoskeletal Tumor Center of Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Xie, M.D.

CONTACT

+86-13401044719; sweetdoctor@163.com

Jie Xu, M.D.

CONTACT

+86-15901040835; xujie_pkuph@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: January 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: March 30, 2019
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

CN (3)