Neoplasms

All Conditions

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Carcinoma, Renal Cell

Exanthema

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

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Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

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Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

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Male Urogenital Diseases

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Sorafenib

Skin biopsy prior to sorafenib or regorafenib treatment and when rash appears or 12 weeks into treatment.

skin punch biopsy

Alexey V Danilov, MD

Skin toxicity is a frequently observed side effect in the era of "molecularly targeted therapies". Skin toxicity following administration of protein kinase inhibitors such as sorafenib, regorafenib, lapatinib, sunitinib, and others can be debilitating to the patient, resulting in dose reduction and discontinuation of treatment. The mechanisms of skin toxicity induced by targeted chemotherapy, such as sorafenib or regorafenib, are poorly understood. Further research is warranted to better understand the pathophysiology of drug-related skin toxicity in this setting and develop correction strategies. This study tests the hypothesis that sorafenib and regorafenib interfere with p63 expression and keratinocyte differentiation and skin remodeling.

Eligible study participants will be evaluated clinically for evidence of skin toxicity during their visits to the outpatient Oncology clinics. Study participants will undergo skin biopsies before sorafenib or regorafenib treatment is initiated and once rash develops or 12 weeks into treatment with sorafenib or regorafenib. Skin biopsies will be performed in Oncology clinics by the study investigators and clinic support staff.

Study participants will undergo both skin biopsies regardless of whether they develop a rash. In patients who develop a rash the most representative lesion will be biopsied. A normal appearing area of skin will be biopsied in participants who do not develop a rash.

skin biopsies will be performed using a 4mm biopsy punch. Participants will undero 2 skin biopsies - one prior to starting sorafenib or regorafenib, the other once rash develops. If a rash does not develop within 84 days a biopsy of normal skin will be done.

Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin

A Study of the Effect of Sorafenib or Regorafenib on p63 Expression and Keratinocyte Differentiation in Human Skin

Tissue collection is done within 7 days prior to treatment and when rash develops. If no rash develops, normal skin will be biopsied at week twelve of treatment.

Sorafenib and regorafenib potentially interfere with p63 expression and keratinocyte differentiation and skin remodeling. The extent of interference may indicate extent of tumor response.

Dartmouth-Hitchcock Medical Center

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Cardiotoxicity

Breast Diseases

Skin Diseases

Trastuzumab

In study participants undergoing breast reconstruction surgery prior to breast radiation therapy, we will obtain skin tissue at the time of reconstruction surgery from the surgical specimen.

Angel Chan, MD, PhD

Richard Steingart, MD

The purpose of this study is to investigate whether cells from a biopsy taken from the patient skin can be transformed into cardiomyocytes the changes in cardiomyocyte (heart muscle cells) when grown in a special culture medium outside of the body. The structure and function of these cells will then be studied to determine why some patients with breast cancer who are treated with chemotherapy including anthracycline (e.g. Doxorubicin) and anti-HER2 therapy (e.g. Herceptin) develop decreased heart function.

Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients

Generation of Induced Pluripotent Stem Cell Derived Cardiomyocytes From Patients Exposed to Trastuzumab Therapy for Breast Cancer

described by Yamanaka et al with modification using the Millipore STEMCCA excisable polycystronic lentivirus reprogramming kit.2

Icahn School of Medicine at Mount Sinai

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin	NCT01466504	Renal Cell Carc... Hepatocellular ... Colorectal Carc...	skin punch biop...	18 Years -	Dartmouth-Hitchcock Medical Center
Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin	NCT01466504	Renal Cell Carc... Hepatocellular ... Colorectal Carc...	skin punch biop...	18 Years -	Dartmouth-Hitchcock Medical Center
Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients	NCT02772367	Breast Cancer	skin punch biop...	18 Years -	Memorial Sloan Kettering Cancer Center
Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients	NCT02772367	Breast Cancer	skin punch biop...	18 Years -	Memorial Sloan Kettering Cancer Center
Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin	NCT01466504	Renal Cell Carc... Hepatocellular ... Colorectal Carc...	skin punch biop...	18 Years -	Dartmouth-Hitchcock Medical Center
Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin	NCT01466504	Renal Cell Carc... Hepatocellular ... Colorectal Carc...	skin punch biop...	18 Years -	Dartmouth-Hitchcock Medical Center

Spots Global Cancer Trial Database for skin punch biopsy