Clinical trial NCT00579566: Novel Biochemical and Molecular Determinants for Soft Tissue Sarcoma
Official title: Novel Biochemical and Molecular Determinants for Soft Tissue Sarcoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoma
Keywords: Biochemical Determinants
Molecular Determinants
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen or referred by Memorial Sloan-Kettering Cancer physicians

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.

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

Primary outcomes:
measure: establish and maintain a specimen bank and sarcoma cell line resource
timeFrame: 2 years
Secondary outcomes:
measure: identify new rational therapeutic targets
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent and Followup)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent and Follow up)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent and Follow-Up)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent and Followup)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Consent and Followup)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Singer Singer, MD
role: PRINCIPAL_INVESTIGATOR
References: