Novel Biochemical and Molecular Determinants for Soft Tis... | NCT00579566

Studies
Novel Biochemical and Molecular Determinants for Soft Tissue Sarcoma

NCT00579566

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Recruiting

Last Update Posted

Jul 30, 2025Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Sarcoma

Interventions

Specimen protocol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2002Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Dec 19, 2007

First Submission Date that Met QC Criteria

Dec 19, 2007

First Posted Date

Dec 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2025

Last Update Posted Date

Jul 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to study normal and sarcoma cells. To study these cells we need to have human tissue. You will be having or have already had a procedure to remove tissue. We would like to use some of this tissue. We will use it for laboratory studies on the diagnosis,behavior and treatment of sarcoma. We will perform an extensive analysis of your samples. We will only use extra tissue left over after all needed testing has been done or remove an additional small amount of tissue if you are having a biopsy. We will also take blood samples before and/or after your procedure to measure biochemical factors that may help us predict the behavior of sarcoma.

Detailed Description

In this protocol, we plan to identify specific markers from biochemical, proteomic, epigenetic and molecular genetic analyses that predict clinical outcome, responsiveness to therapy and might serve as promising therapeutic targets in patients with soft tissue sarcoma.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Sarcoma patients undergoing core biopsy, incisional biopsy or definitive surgical resection for soft tissue masses of extremity, trunk or retroperitoneum	Other: Specimen protocol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Specimen protocol	Other	The research specimen will be obtained from the residual specimen that would otherwise be discarded per usual hospital procedure.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
establish and maintain a specimen bank and sarcoma cell line resource	for laboratory-based studies on the causes, prevention, diagnosis and treatment of human soft tissue sarcoma	2 years

Secondary Outcomes

Measure	Description	Time Frame
identify new rational therapeutic targets		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with known or suspected sarcoma who will have or have had tissue removed for therapeutic or diagnostic purposes.
Patients will be entered without preference for any particular racial/ethnic group or gender.
Patients may have received prior hormonal therapy, cytotoxic chemotherapy, irradiation, immunotherapy or surgical therapy.
Tissue specimens must be large enough in quantity to allow routine pathologic analysis, with the research laboratory specimen removed from the residual specimen, which would otherwise be discarded. Optimal tissue amounts for snap freeze: Core biopsy - 2 tissue cores Incisional biopsy- 0.5 to 1.5 grams Resected sarcoma specimen- 1.0 to 50 grams depending on size of specimen Normal fat or muscle tissue - 0.5 to 4.0 grams (if available from resected sarcoma specimen) Optimal tissue amounts for RNA later Core biopsy - 2 tissue cores Incisional biopsy- 30 mg (three 3 x 3 x 3 mm cubes) Resected sarcoma specimen - 30 mg (three 3 x 3 x 3 mm cubes) Normal fat or muscle tissue - 30 mg (three 3 x 3 x 3 mm cube

Exclusion Criteria:

- None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients seen or referred by Memorial Sloan-Kettering Cancer physicians

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samuel Singer, MD	Contact	212-639-2940
Aimee Crago, MD, PhD	Contact

Overall Officials

Name	Affiliation	Role
Singer Singer, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up)	Recruiting	Basking Ridge	New Jersey	07920	United States

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms