Melanocytic NeviNCT00288938
Natural History Study of Moles and Suspicious Melanoma
An observational study of Melanocytic Nevi and Acquired Melanocytic Nevi, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Melanocytic Nevi, Acquired Melanocytic Nevi, Primary Cutaneous Melanoma
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2006to 31 Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants/Children
- Must be less than or equal to 5 years.
- 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.
- OR
- Adults
Show all 18Show fewer
- 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.
- OR
- Adults
- Must be greater than 18 years.
- Must have a current pigmented lesion clinically suspicious for primary melanoma.
- Must have outside primary physician.
- AND
- All patients, or in the case of infants and children their parents or legal guardians, must be able to understand and sign an informed consent.
Who cannot join
- The patient does not meet the inclusion criteria.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Dermoscopic Diagnosis, Histopathological Correlation, and Cellular Immortalization of Melanocytic Nevi and Primary Cutaneous Melanoma
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)
Read more
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)
Read the detailed description
The objective of this study is to understand early transformation and malignant progression events of cutaneous melanoma by obtaining detailed clinical information and lesional tissue for analysis, cell culture, and immortalization from patients with melanocytic nevi, which frequently are precursor lesions of melanoma, and primary melanoma. An important goal of this study is the acquisition of melanocytes from lager congential melanocytic nevi (LCMN) and acquired melanocytic nevi (AMN) for analysis, culture and experimental manipulation. We do not propose to acquire melanocytes from pigmented lesions suspected to represent primary melanoma because of the importance of preserving all lesional tissue required to render accurate histopathological diagnosis. However, another aim of the study is the development of enhanced clinical criteria for the diagnosis of primary cutaneous melanoma, particularly using digital epiluminescent skin microscopy, or dermoscopy, for pigmented lesion image acquisition and analysis. The close comparison of dermoscopic images of pigmented skin lesions suspicious for melanoma with lesional histopathology should be useful for expanding the knowledge base about how dermoscopy , a relatively new technique used to evaluate pigmented skin lesions, can be used to diagnose a pigmented skin lesion as benign or malignant. These detailed comparisons may also provide information about how specific visual features within the dermoscopic image field correlate with histologic features of the lesion. This information may be useful for future possible studies designed to predict accurately which portions of a primary malignant melanoma can be removed for esperimental study while retaining sufficient lesional information to guide further treatment and render an accurate prognosis.
The study population will consist of three categories of patients: (1) infants and children with large congenital melanocytic nevi, (2) adults with numerous (less than 100) melanocytic nevi, and (3) patients with primary malignant melanoma. Establishment of the Pigmented Lesion Clinic required for the execution of this protocol will provide a mechanism for the evaluation of patients with numerous or unusual pigmented lesions, and for the entry of eligible patients into ongoing therapeutic trials for malignant melanoma. As the study progresses, it is anticipated that a substantial amount of formalin-fixed nevus and primary melanoma tissue with a high-degree of clinical annotation will be collected. As a secondary objective , the availability of this collection will be useful to support studies designed to evaluate new markers and techniques for the diagnosis of melanoma and atypical nevi, and for incorporation into a tissue microarray that will be available to the melanoma research community for target foundation validation.
Background:
The molecular events resulting in melanocyte transformation and the development of early melanoma are incompletely understood. Risk factors for the development of melanoma include genetic, phenotypic and environmental risk factors and can overlap. Also, persons with large numbers of nevi face a higher risk of melanoma. These risk associations, combined with knowledge obtained from basic studies on the survival, differentiation, and proliferation of the melanocyte, can provide hints about the molecular mechanisms that underlie the development of nevi and melanoma.
In this study we plan to acquire lesional tissue from pigmented lesions and develop enhanced clinical criteria for the diagnosis of primary cutaneous melanoma, particularly using digital epiluminescent skin microscopy, or dermoscopy, for pigmented lesion image acquisition and analysis. This information may be useful for future possible studies designed to predict accurately which portions of a primary malignant melanoma can be removed for experimental study while retaining sufficient lesional information to guide further treatment and render an accurate prognosis.
Objectives:
To obtain tissue from benign melanocytic nevi and from large congenital melanocytic nevi (LCMN) for experimental study.
To refine culture and immortalization methods for melanocytes derived from melanocytic nevi, permitting in vitro expansion of these cells for functional study.
To correlate clinical and dermoscopic observations of primary melanomas with histopathology to establish standards for sampling primary melanomas in a possible future study.
Eligibility:
Infants/Children less than 5 years of age with 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.
Adults greater than 18 years of age with greater than 100 melanocytic nevi greater than 2 mm in diameter with at least one melanocytic nevus greater than 4 mm in longest dimension or with a current pigmented lesion clinically suspicious for primary melanoma.
Design:
This is a natural history protocol designed to enroll 110 subjects who will be evaluated and followed over the course of their disease.
- Keywords
- Suspicious mole, Congenital Nevus, Skin Cancer, Moles, Pigmented lesion, LCMN
- Medical subject headings
- Nevus, Pigmented, Skin Neoplasms, Nevus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study start3 Feb 2006
- Study completion31 Oct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Melanocytic NeviStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288938
- Sponsor's protocol ID
- 060060
- Other IDs
- 06-C-0060
- Status last verified
- 31 Oct 2011
- First submitted
- 8 Feb 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 10766187Bastian 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.
PubMed 9605762Bataille 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.
PubMed 9472652
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermoscopic Diagnosis, Histopathological Correlation, and Cellular Immortalization of Melanocytic Nevi and Primary Cutaneous Melanoma
- ClinicalTrials.gov ID
- NCT00288938
- Acronym / sponsor ID
- 060060
- Keywords
- Suspicious mole, Congenital Nevus, Skin Cancer, Moles, Pigmented lesion, LCMN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 3 Feb 2006
- Study completion
- 31 Oct 2011
- First posted
- 8 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
The objective of this study is to understand early transformation and malignant progression events of cutaneous melanoma by obtaining detailed clinical information and lesional tissue for analysis, cell culture, and immortalization from patients with melanocytic nevi, which frequently are precursor lesions of melanoma, and primary melanoma. An important goal of this study is the acquisition of melanocytes from lager congential melanocytic nevi (LCMN) and acquired melanocytic nevi (AMN) for analysis, culture and experimental manipulation. We do not propose to acquire melanocytes from pigmented lesions suspected to represent primary melanoma because of the importance of preserving all lesional tissue required to render accurate histopathological diagnosis. However, another aim of the study is the development of enhanced clinical criteria for the diagnosis of primary cutaneous melanoma, particularly using digital epiluminescent skin microscopy, or dermoscopy, for pigmented lesion image acquisition and analysis. The close comparison of dermoscopic images of pigmented skin lesions suspicious for melanoma with lesional histopathology should be useful for expanding the knowledge base about how dermoscopy , a relatively new technique used to evaluate pigmented skin lesions, can be used to diagnose a pigmented skin lesion as benign or malignant. These detailed comparisons may also provide information about how specific visual features within the dermoscopic image field correlate with histologic features of the lesion. This information may be useful for future possible studies designed to predict accurately which portions of a primary malignant melanoma can be removed for esperimental study while retaining sufficient lesional information to guide further treatment and render an accurate prognosis.
The study population will consist of three categories of patients: (1) infants and children with large congenital melanocytic nevi, (2) adults with numerous (less than 100) melanocytic nevi, and (3) patients with primary malignant melanoma. Establishment of the Pigmented Lesion Clinic required for the execution of this protocol will provide a mechanism for the evaluation of patients with numerous or unusual pigmented lesions, and for the entry of eligible patients into ongoing therapeutic trials for malignant melanoma. As the study progresses, it is anticipated that a substantial amount of formalin-fixed nevus and primary melanoma tissue with a high-degree of clinical annotation will be collected. As a secondary objective , the availability of this collection will be useful to support studies designed to evaluate new markers and techniques for the diagnosis of melanoma and atypical nevi, and for incorporation into a tissue microarray that will be available to the melanoma research community for target foundation validation.
Background:
The molecular events resulting in melanocyte transformation and the development of early melanoma are incompletely understood. Risk factors for the development of melanoma include genetic, phenotypic and environmental risk factors and can overlap. Also, persons with large numbers of nevi face a higher risk of melanoma. These risk associations, combined with knowledge obtained from basic studies on the survival, differentiation, and proliferation of the melanocyte, can provide hints about the molecular mechanisms that underlie the development of nevi and melanoma.
In this study we plan to acquire lesional tissue from pigmented lesions and develop enhanced clinical criteria for the diagnosis of primary cutaneous melanoma, particularly using digital epiluminescent skin microscopy, or dermoscopy, for pigmented lesion image acquisition and analysis. This information may be useful for future possible studies designed to predict accurately which portions of a primary malignant melanoma can be removed for experimental study while retaining sufficient lesional information to guide further treatment and render an accurate prognosis.
Objectives:
To obtain tissue from benign melanocytic nevi and from large congenital melanocytic nevi (LCMN) for experimental study.
To refine culture and immortalization methods for melanocytes derived from melanocytic nevi, permitting in vitro expansion of these cells for functional study.
To correlate clinical and dermoscopic observations of primary melanomas with histopathology to establish standards for sampling primary melanomas in a possible future study.
Eligibility:
Infants/Children less than 5 years of age with 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.
Adults greater than 18 years of age with greater than 100 melanocytic nevi greater than 2 mm in diameter with at least one melanocytic nevus greater than 4 mm in longest dimension or with a current pigmented lesion clinically suspicious for primary melanoma.
Design:
This is a natural history protocol designed to enroll 110 subjects who will be evaluated and followed over the course of their disease.
Study design
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Infants/Children
- Must be less than or equal to 5 years.
- 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.
- OR
Key exclusion criteria (6 listed)
- The patient does not meet the inclusion criteria.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 10766187Bastian 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.
- Background: PubMed 9605762Bastian 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.
- Background: PubMed 9472652Bataille 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanocytic Nevi and Acquired Melanocytic Nevi, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00288938, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.