A Phase 2 interventional study of Biopsy Procedure and Biospecimen Collection in Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8 and Clinical Stage II Cutaneous Melanoma AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by ECOG-ACRIN Cancer Research Group · Phase 2, Interventional, and Prevention
This phase II trial tests how well sulforaphane works in preventing melanoma in patients with multiple atypical moles (nevi) and a prior history of melanoma. Patients with a history of melanoma and multiple atypical nevi are at a significantly increased risk of developing additional melanomas than those without atypical nevi. Prevention measures usually include sun protection, monthly skin self-examinations and regular skin examinations from a doctor. Sulforaphane is a naturally-occurring substance found in many cruciferous vegetables, including broccoli, that may prevent melanoma from forming.
PRIMARY OBJECTIVE:
I. To evaluate the effects of oral sulforaphane versus (vs) placebo on change in the total area of atypical and common pigmented nevocellular nevi on the posterior trunk at 12 months after randomization as assessed by digital photographic imaging and analysis using Derma-AI image analysis software, specifically assessed in patients treated for the entire 12-month treatment period (per-protocol analysis).
SECONDARY OBJECTIVES:
I. To evaluate the effects of oral sulforaphane vs placebo on the number of atypical and common pigmented nevocellular nevi with moderate and significant changes in area on the posterior trunk at 12 months after randomization as assessed by digital photographic imaging and analysis using Derma-AI image analysis software, specifically assessed in patients treated for the entire 12-month treatment period (Intent-to-Treat [ITT] analysis).
II. To determine the effects of 12 months of sulforaphane treatment versus vs placebo on the total area and features of atypical nevi at 12 months, assessed as above in all randomized patients.
III. To assess the safety/tolerability of sulforaphane (three Avmacol® Extra Strength [Nutramax] tablets once daily over 12 months), assessed per Common Terminology Criteria for Adverse Events (CTCAE), as well as by dosing deviations among all treated patients.
EXPLORATORY OBJECTIVES:
I. Effects of sulforaphane on inflammation and immunity:
Ia. To evaluate the effects of sulforaphane on circulating serum cytokine and chemokine levels, as assessed by multiplex technology (Luminex or similar); Ib. To evaluate the effects of sulforaphane on immune cell infiltration in atypical melanocytic nevocellular nevi, as assessed by traditional histopathology and immunohistochemistry.
III. To evaluate dermoscopic features of targeted prespecified atypical melanocytic nevocellular nevi at each timepoint.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive sulforaphane orally (PO) twice daily (BID) for up to 12 months in the absence of unacceptable toxicity. Patients also undergo optional excisional biopsy at baseline, 3 and 12 months and post treatment and blood sample collection throughout study.
ARM B: Patients receive placebo PO BID for up to 12 months in the absence of unacceptable toxicity. Patients also undergo optional excisional biopsy at baseline, 3 and 12 months and post treatment and blood sample collection throughout study.
After completion of study treatment, patients are followed every 3 months for 24 months from randomization.
24 studies on the registry are indexed under Dysplastic Nevus Syndrome; 7 are open to participants now.
Browse Dysplastic Nevus Syndrome studies →ECOG-ACRIN Cancer Research Group is the lead sponsor of 122 studies on the registry; 16 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.
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Inclusion Criteria:
Patient must have ≥ 3 clinically atypical nevi, assessed within 30 days prior to randomization, that are consistent with the International Agency for Research on Cancer (IARC) definition as follows.
Patient must not be pregnant. All patients of must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive sulforaphane PO BID for up to 12 months in the absence of unacceptable toxicity. Patients also undergo optional excisional biopsy at baseline, 3 and 12 months and post treatment and blood sample collection throughout study.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Drug: Sulforaphane
Patients receive placebo PO BID for up to 12 months in the absence of unacceptable toxicity. Patients also undergo optional excisional biopsy at baseline, 3 and 12 months and post treatment and blood sample collection throughout study.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Drug: Placebo Administration
Undergo optional excisional biopsy
Also known as: Biopsy, BIOPSY_TYPE, Bx
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Given PO
Given PO
Also known as: (+/-)-Sulforaphane, 1-isothiocyanato-4-methylsulfinyl-butane, Sulfaforaphane, Sulforafan, Sulphoraphane
Change in total area of atypical and common pigmented nevocellular nevi on the posterior trunk
Changes in the total area of nevi compared between the arms will be assessed by Derma-AI digital photographic imaging and analysis using image analysis software. The difference in the change of total area of nevi between the two arms will be compared using the Wilcoxon rank sum test.
Time frame: From baseline to 12 months after randomization
Number of changed atypical nevi on the posterior trunk
The number of changed atypical nevi will be assessed via automated image analysis. The difference in baseline and post-treatment measures will be compared between the two arms using the Wilcoxon rank-sum test. Both intent-to-treat and per-protocol analyses will be conducted.
Time frame: At baseline and 12 months after randomization
Incidence of adverse events (AEs)
Incidence of AEs assessed per Common Terminology Criteria for Adverse Events as well as by dosing deviations. Toxicity rate for individual AEs, categorized AEs and worst degree AEs will be compared between the two arms using the Fisher's exact test.
Time frame: Up to 12 months
Circulating serum cytokine and chemokine levels
Assessed by multiplex technology. The Wilcoxon rank-sum test will be used to compare the level of each value between timepoints. The Wilcoxon rank-sum test will be used to compare changes in levels between patients receiving sulforaphane and placebo.
Time frame: At baseline and at 3 and 12 months
Immune cell infiltration
Assessed by traditional histopathology and immunohistochemistry. Traditional histopathologic features of nevi will be reported descriptively. The Wilcoxon rank-sum test will be used to compare changes in levels between patients.
Time frame: At baseline and at 3 and 12 months
Dermoscopic features of the atypical nevi
Dermoscopy and dermoscopic photographs will be performed on the index nevi at each timepoint, and morphologic features will be reported descriptively.
Time frame: Up to 12 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Sulforaphane
ECOG-ACRIN Cancer Research Group →