An Early Phase 1 interventional study of broccoli sprout extract - sulforaphane (BSE-SFN) and broccoli sprout extract - sulforaphane (BSE-SFN) in Atypical Nevi and Melanoma, sponsored by John Kirkwood. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-09.
Sponsored by John Kirkwood · Early Phase 1, Interventional, and Prevention
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Among 17 studies in Dysplastic Nevus Syndrome with a site in United States — 5 open to participants now, 6 under way, 1 of them phase 3. Dysplastic Nevus Syndrome · United States.
Among the 17 studies in Dysplastic Nevus Syndrome with a site in United States, this one is the only one that started in 2012, is the only one in phase 1, and was the 6th registered.
24 studies on the registry are indexed under Dysplastic Nevus Syndrome; 7 are open to participants now.
Browse Dysplastic Nevus Syndrome studies →5 of the 17 studies in Dysplastic Nevus Syndrome with a site in United States are open now. Recruiting first, the newest first:
ECOG-ACRIN Cancer Research Group · Sites in United States
Ages 18+
John Kirkwood · Sites in United States
Ages 18+
Johns Hopkins University · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 4 wk–99 yrs · Healthy volunteers
Orlucent, Inc · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Dysplastic Nevus Syndrome studies recruiting now, 4 set no upper age limit and none stop at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 1
First in 1999; this study’s year is marked. 1 started in 2012.
Median enrollment 78 across the 6 interventional studies, 265 across the 11 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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4 of 17 have an industry lead sponsor. The 10 most frequent:
John Kirkwood is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
John Kirkwood has 2 studies filed under Dysplastic Nevus Syndrome — fewer than ten, so there is no comparison to draw.
1 of the studies in Dysplastic Nevus Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05692596H. Lee Moffitt Cancer Center and Research InstituteThe Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics | 2027-07 |
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Among the 17 studies in Dysplastic Nevus Syndrome with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a pilot study to see if oral administration of freeze dried, powdered broccoli sprouts have any effect on whether moles end up becoming melanoma.
This study is designed as a pilot evaluation of sulforaphane as a candidate natural nutritional chemopreventive agent able to modulate key steps in melanoma progression and the expression of STAT proteins in melanocytic and stromal elements of atypical nevi, which are precursor lesions and risk markers of melanoma. Eighteen individuals in total will receive oral broccoli sprout extract rich in sulforaphane (BSE-SFN) standardized for 3 different concentrations of actual sulforaphane content which will be utilized in our study. Three groups of six patients will be randomly assigned to receive oral BSE-SFN at SFN dosages of 50 µmol, 100 µmol, or 200 µmol daily. Due to the established safety of SFN at all of the proposed dosage levels, there is no plan to complete a lower dosage level prior to escalating to the next higher dosage level; i.e., subjects will be randomized across all of the proposed SFN dosage levels. However, the safety of BSE-SFN administration will continue to be evaluated through laboratory studies (CBC, chemistry) performed before and following 28 days of administration.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
N/A
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BSE-SFN will be orally administered at 50 µmol SFN for 28 days.
Drug: broccoli sprout extract - sulforaphane (BSE-SFN)
BSE-SFN will be orally administered at 100 µmol SFN for 28 days.
Drug: broccoli sprout extract - sulforaphane (BSE-SFN)
BSE-SFN will be orally administered at 200 µmol SFN for 28 days.
Drug: broccoli sprout extract - sulforaphane (BSE-SFN)
50 µmol capsules, taken orally, once a day for 28 days
100 µmol capsules, taken orally, once a day for 28 days
200 µmol capsules, taken orally, once a day for 28 days
Adverse events associated with oral sulforaphane
Time frame: 2 years
Visual changes of atypical nevi: size, border, color.
Time frame: 2 years
Cellular changes of the atypical nevi.
Time frame: 2 years
Sulforaphane levels in the blood as a result of the 3 doses.
Time frame: 2 years
Effects of sulforaphane on STAT1 and STAT3 expression.
Time frame: 2 years
Ran from Aug 2012 to primary completion in Mar 2016, 43 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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John Kirkwood