Peripheral Blood and/or Bone Marrow, Including Detection... | NCT00588198

Studies
Peripheral Blood and/or Bone Marrow, Including Detection of Occult Metastases, in Patients With Melanoma

NCT00588198

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Completed

Last Update Posted

Sep 28, 2023Actual

Enrollment

754Actual

Phase

Not provided

Conditions

Melanoma

Interventions

Not provided

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1991

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Dec 24, 2007

First Submission Date that Met QC Criteria

Jan 7, 2008

First Posted Date

Jan 8, 2008Estimated

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

Sep 25, 2023

Last Update Posted Date

Sep 28, 2023Actual

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 determine if tumor cells can be detected in the peripheral blood and/or bone marrow of patients with melanoma.

Detailed Description

Patients with melanoma can succumb to subclinical metastatic disease, not detectable at presentation by conventional physical examination, hematologic and biochemical screening, or radiologic evaluation. More intensive radiologic evaluation with CT or radioisotope scanning has not proven to be useful. What may be useful is a more sensitive method of staging melanoma patients at presentation, specifically evaluating them for subclinical systemic disease.

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

754Actual

Label	Type	Description	Intervention Names
1		Melanoma patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the sensitivity of RT-PCR to detect evidence of melanoma cells in bone marrow and/or peripheral blood and estimate sensitivity separately for each of the different stage groupings for melanoma		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

MSK Patients with histologically confirmed melanoma of any site and at least one of the following:

Primary tumor > 4.0 mm thick (AJCC Stage IIB)
Clinically or histologically positive regional nodes (AJCC Stage III)
Any in transit disease (AJCC Stage III)
Any systemic metastases (AJCC Stage IV)

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

Melanoma Patients seen at Memorial Sloan-Kettering Cancer Center (MSK)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Cancer Center		New York	New York	10065	United States

Label	URL
Memorial Sloan-Kettering Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided