A Phase 2 interventional study of Quercetin (dietary supplement) in Fanconi Anemia and Squamous Cell Carcinoma, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 2, Interventional, and Prevention
Among 68 studies in Fanconi Anemia with a site in United States — 14 open to participants now, 18 under way, none of them phase 3. Fanconi Anemia · United States.
Among the 68 studies in Fanconi Anemia with a site in United States, this one is the 7th largest by enrollment of the 48 interventional ones that give a count, is one of 5 that started in 2018, is one of 15 in phase 2, and was the 53rd registered.
95 studies on the registry are indexed under Fanconi Anemia; 20 are open to participants now.
Browse Fanconi Anemia studies →14 of the 68 studies in Fanconi Anemia with a site in United States are open now. Recruiting first, the newest first:
Rockefeller University · Sites in United States
Ages 18+
University of Minnesota · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 8–90
Masonic Cancer Center, University of Minnesota · Sites in United States
Ages 18–45 · Healthy volunteers
Porteus, Matthew, MD · Sites in United States
Ages 2+
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 15 Fanconi Anemia studies recruiting now, 8 (53%) set no upper age limit and 5 (33%) stop at 75 or younger; 11 take children under 18; 2 take healthy volunteers.
This study: 2 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.
68 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 22 · Phase 2 26 · Phase 3 2
First in 1975; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 48 is above the median of 21 across 61 interventional studies indexed under Fanconi Anemia.
Median enrollment 21 across the 48 interventional studies, 67 across the 17 observational. Of the 47 that completed or were terminated, 17 (36%) have results posted.
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3 of 68 have an industry lead sponsor. The 10 most frequent:
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 129 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Children's Hospital Medical Center, Cincinnati has 7 studies filed under Fanconi Anemia — fewer than ten, so there is no comparison to draw.
5 of the studies in Fanconi Anemia 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 |
|---|---|
| NCT02143830Children's Hospital Medical Center, CincinnatiHSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy | 2026-12 |
| NCT05973656Masonic Cancer Center, University of MinnesotaRole of Acetaldehyde in the Development of Oral Cancer | 2027-01-01 |
| NCT03579875Masonic Cancer Center, University of MinnesotaAlpha/Beta TCD HCT in Patients With Inherited BMF Disorders | 2027-01-01 |
| NCT03924401Emory UniversityAcute GVHD Suppression Using Costimulation Blockade to Expand Non-malignant Transplant | 2027-03-01 |
| NCT00542373M.D. Anderson Cancer CenterWidefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer | 2027-04-30 |
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Among the 68 studies in Fanconi Anemia with a site in United States, from their registry updates:
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Fanconi anemia (FA) is an autosomal recessive disease characterized by progressive bone marrow failure, variable congenital abnormalities and a predisposition to malignancy, particularly acute myeloid leukemia (AML) and squamous cell carcinoma (SCC). Improved transplant outcomes are modifying the natural history of Fanconi Anemia. Improved transplant survival, no radiation exposure, and almost no GVHD increases the importance of addressing later SCC even further. The investigators hypothesize that quercetin will prevent or delay the development of SCC and associated complications, there by ameliorating or delaying the need for potentially lethal treatment with chemotherapy and/or radiation therapy for the same.
Funding Source - FDA Office of Orphan Products Development (OOPD)
Fanconi anemia (FA) is an autosomal recessive disease characterized by progressive bone marrow failure, variable congenital abnormalities and a predisposition to malignancy, particularly acute myeloid leukemia (AML) and squamous cell carcinoma (SCC). Currently, the only curative treatment option for the hematological complications of FA include hematopoietic cell transplantation (HCT). The investigators hypothesize that quercetin will prevent or delay the development of SCC and associated complications, there by ameliorating or delaying the need for potentially lethal treatment with chemotherapy and/or radiation therapy for the same.
This study is an open-label, single arm study. This study will enroll approximately 45 post-HCT patients with FA, and approximately 10 patients with FA without history of HCT. In both groups, patients with or without existing pre-malignant lesions or history of SCC will be allowed to participate, if they wish so and at the discretion of the PI. All patients will be treated with oral quercetin.
The investigators will determine the efficacy of Quercetin in reducing buccal micronuclei (a surrogate marker of DNA damage and susceptibility to squamous cell carcinoma due to genomic instability) in post-HCT patients with fanconi anemia (FA).
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:
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.
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.
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.
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.
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.
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.
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.
All patients will be treated with oral quercetin.
Drug: Quercetin (dietary supplement)
Quercetin will be administered twice daily at an adjusted dose based on weight for a maximum total daily dose of 4000mg/day. If the patient is 70 kg or more, the dose will automatically be assigned at the maximum dose of 4000mg/day.
Number of Participants With at Least 20% Reduction of Buccal Micronuclei
Efficacy of Quercetin in reducing buccal micronuclei. A 20% reduction in the average total number of micronuclei will be considered a success of the intervention.
Time frame: 1 year
| Milestone | Quercetin |
|---|---|
| Started | 48 |
| Completed | 29 |
| Not completed | 19 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Physician decision | 2 |
| Withdrew: Withdrawal by subject | 15 |
Efficacy of Quercetin in reducing buccal micronuclei. A 20% reduction in the average total number of micronuclei will be considered a success of the intervention.
| Participants | Quercetin |
|---|---|
| Number of Participants With at Least 20% Reduction of Buccal Micronuclei | 13 |
Collected over Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quercetin | 0/47 (0%) | 3/47 (6.4%) | 10/47 (21.3%) |
| Event | Quercetin |
|---|---|
| Other: Crohn's disease flareGastrointestinal disorders | 1/47 |
| Lung infectionInfections and infestations | 1/47 |
| Urinary tract infectionInfections and infestations | 1/47 |
| Upper respiratory infectionInfections and infestations | 1/47 |
| PneumonthoraxRespiratory, thoracic and mediastinal disorders | 1/47 |
| Respiratory distressRespiratory, thoracic and mediastinal disorders | 1/47 |
| Event | Quercetin |
|---|---|
| Weight GainInvestigations | 6/47 |
| DiarrheaGastrointestinal disorders | 2/47 |
| Worsening gastritisGastrointestinal disorders | 1/47 |
| VomitingGastrointestinal disorders | 1/47 |
| Other: Biliary dyskinesiaHepatobiliary disorders | 1/47 |
| AnorexiaMetabolism and nutrition disorders | 1/47 |
| InsomniaPsychiatric disorders | 1/47 |
| Rash maculo (legs)Skin and subcutaneous tissue disorders | 1/47 |
| Rash maculo-papular (back)Skin and subcutaneous tissue disorders | 1/47 |
| PruritusSkin and subcutaneous tissue disorders | 1/47 |
| Age, Categorical(Participants) | Quercetin |
|---|---|
| <=18 years | 36 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Quercetin |
|---|---|
| Female | 24 |
| Male | 24 |
| Race (NIH/OMB)(Participants) | Quercetin |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 44 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Mar 2025, 81 months.
Results were first posted in Apr 2026, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Quercetin
Children's Hospital Medical Center, Cincinnati →