NCT00288938

Completed

Natural History Study of Moles and Suspicious Melanoma

National Cancer Institute (NCI)Source

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Other study identifiers

Sponsor study identifier

060060

Secondary identifiers

06-C-0060

Study Type

observational

Actual enrollment (reported)

20

Locations

1 country

Sites

1

Timeline

Study Start

February 3, 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

October 31, 2011

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

Background:

Melanocytic nevi, or "moles," are non-cancerous growths of a type of skin cell called a melanocyte.
Large congenital melanocytic nevi (LCMN) are a special type of mole that begins to grow before birth and is larger than moles that develop after birth.
Determining how melanocytes in moles and LCMNs differ from normal melanocytes may increase the ability to predict whether a mole will give rise to a melanoma (a type of skin cancer) Objectives:
To understand how melanomas develop, by studying moles, LCMNs, and pigmented skin lesions that are suspicious for melanoma
To develop better criteria for diagnosing melanoma, particularly by using a device called a digital dermatoscope (a special camera, connected to a computer, that takes pictures of moles when they are magnified and illuminated) Eligibility:
Children 5 years old or older with an LCMN
Adults 18 years old or older with 100 or more moles larger than 2 mm in diameter and at least one 4 mm or more
Adults 18 years old or older with a pigmented lesion suspicious for melanoma Design:
Patients' personal and family health history is obtained.
Patients are examined by investigative team doctors, and several lesions are examined with a dermatoscope.
Additional photographs of part or all of the skin surface may be taken.
Some lesions may be biopsied.
Additional tests or examinations may be recommended.
Patients are followed periodically for skin or physical examinations, photography, laboratory and imaging evaluations, and possible skin biopsies.
Children may undergo brain magnetic resonance imaging (MRI)

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 20 participants
Study completion date: October 31, 2011
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 3, 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
February 8, 2006
Actual (reported)
First Posted
February 8, 2006
Actual (reported)
Study Completion
October 31, 2011
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: July 2, 2017
Status Verified: October 31, 2011
Last Update Submitted: June 30, 2017

Conditions

Acquired Melanocytic Nevi Melanocytic Nevi Primary Cutaneous Melanoma

Keywords

Suspicious moleCongenital NevusSkin CancerMolesPigmented lesionLCMN

Eligibility Criteria

Age5 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Infants/Children
Must be less than or equal to 5 years.

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHlead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Related Publications (3)

Bastian BC, Kashani-Sabet M, Hamm H, Godfrey T, Moore DH 2nd, Brocker EB, LeBoit PE, Pinkel D. Gene amplifications characterize acral melanoma and permit the detection of occult tumor cells in the surrounding skin. Cancer Res. 2000 Apr 1;60(7):1968-73.
PMID: 10766187BACKGROUND
Bastian BC, LeBoit PE, Hamm H, Brocker EB, Pinkel D. Chromosomal gains and losses in primary cutaneous melanomas detected by comparative genomic hybridization. Cancer Res. 1998 May 15;58(10):2170-5.
PMID: 9605762BACKGROUND

MeSH Terms

Conditions

Nevus, PigmentedSkin NeoplasmsNevus

Condition Hierarchy (Ancestors)

Nevi and MelanomasNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Sponsor Type: NIH

Study Record Dates

First Submitted

February 8, 2006

First Posted

February 8, 2006

Study Start

February 3, 2006

Date type not reported

This date has not been verified as actual or estimated.

Completed

NCT05463510

Dermoscopic Monitoring of Pediatric Melanocytic Nevi Regarding Pattern and Diameter Changes

Completed

NCT03699995

MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma

Not ApplicableTerminated

NCT01167998

Early Diagnosis of Malignant Transformation of Pigmentary Skin Lesions

Unknown

NCT04566302

Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy

Not ApplicableCompleted

Must have large congenital melanocytic nevus (LCMN, diagnosed clinically or by biopsy) that is greater than 20 cm in any one dimension or that is greater than 8 cm in any one dimension involving the scalp.

Must have outside referring physician.

Adults

Must be greater than 18 years.

Must have greater than or equal to 100 melanocytic nevi greater than 2 mm in diameter.

Must have at least one melanocytic nevus greater than or equal to 4 mm in longest dimension.

Can have prior history of cutaneous or ocular malignant melanoma.

Must have outside primary physician.

Adults

Must be greater than 18 years.

Must have a current pigmented lesion clinically suspicious for primary melanoma.

Must have outside primary physician.

AND

+1 more criteria

You may not qualify if:

Diagnosis of genetic syndrome associated with multiple lentigines or nevi (Peutz-Jeghers syndrome, Carney complex, turner syndrome, Noonan's syndrome).
Two or more first-degree relatives with history of cutaneous melanoma and familial atypical mole-melanoma syndrome phenotype.
Diagnosis of cancer-associated syndrome (xeroderma pigmentosum, type I neurofibromatosis, Li-Fraumeni syndrome).
Inability to tolerate surgical procedure due to bleeding diathesis or disorder or other cause as determined by principal investigator.
Patient is unwilling to consider elective biopsy of a melanocytic nevus.

Contact the study team to confirm eligibility.

Bataille V, Grulich A, Sasieni P, Swerdlow A, Newton Bishop J, McCarthy W, Hersey P, Cuzick J. The association between naevi and melanoma in populations with different levels of sun exposure: a joint case-control study of melanoma in the UK and Australia. Br J Cancer. 1998;77(3):505-10. doi: 10.1038/bjc.1998.81.

PMID: 9472652BACKGROUND

Study Completion

October 31, 2011

Date type not reported

This date has not been verified as actual or estimated.

Last Updated

July 2, 2017

Record last verified: 2011-10-31

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00288938
Data provider: ClinicalTrials.gov
Source updated: 2017-07-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:21 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations