Dermatologic Agents

All Drugs and Chemicals

Coal Tar

Participant's molecular profile shows that they have a gene mutation that may benefit from study drugs that are believed to target their gene mutation. Participant assigned to Arm A and will receive these targeted drugs.

Participant's molecular profile shows that they do not have a gene mutation. Participant assigned to Arm B in which doctor chooses a therapy based on other studies rather than gene mutation.

Treatment Based on Genetic Mutation

Treatment Based on No Genetic Mutation

Apostolia M. Tsimberidou, MD, PHD

The goal of this laboratory research study is to learn if using molecular information (matched therapy) or not using molecular information and having the study doctor choose the therapy based on your past experience are more effective ways to choose the best cancer treatment for you.

This is an investigational study.

Up to 200 participants will take part in this study. Up to 50 will be enrolled at MD Anderson.

If you agree to take part in this study, your tumor tissue and blood samples will be tested for molecular profiling. Molecular profiling is the classification of tissue based on the expression of certain genes within a tumor compared to normal tissue. This may be used to predict how the tumor responds to therapy. Your doctor may use the results of the molecular profiling to help decide which treatment might be the most beneficial for the disease.

Study Procedures:

Blood (about 2 teaspoons) will be drawn and you will have a tumor biopsy and a biopsy of normal tissue when you enroll in this study. Blood (about 2 teaspoons) will be drawn again about 2-3 weeks after you begin treatment. The type of biopsy you have will depend on the type of disease you have. The risks of this procedure will be discussed in more detail with you.

If there is not enough tissue with which the study doctor can perform the study tests (described below), you may need to have a second biopsy. The study staff will discuss this with you if it is needed.

Treatment Arms:

A series of tests to find which gene mutations you have, if any, will be performed. Depending on the results of your molecular testing, you may be enrolled on 1 of 2 arms.

If your molecular profile shows that you have a gene mutation that may benefit from study drugs that are believed to target your gene mutation, you will be enrolled in Arm A and will receive these targeted drugs.

If your molecular profile shows that you do not have a gene mutation, you will be enrolled in Arm B. In Arm B, the doctor will choose a therapy based on other studies rather than gene mutation.

Length of Study:

This study will last about 2 years. Your participation on this study will be complete after the last blood draw and tumor biopsy is collected.

Blood (about 2 teaspoons) drawn initially and again about 2-3 weeks after chosen treatment begins.

Rational Therapeutics Based on Matched Tumor and Normal Tissue

A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies

Progression-free survival (PFS) of the last therapeutic line (PFS1) before entering into study, with the PFS2 under study treatment. A clinical meaningful improvement is defined as demonstrating a PFS ratio (PFS2/PFS1) of being 1.5 or better.

European Commission

M.D. Anderson Cancer Center

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Skin Neoplasms

Skin Diseases

Pharmaceutical Solutions

Patients who will benefit from the removal of a scalp tumour in the alopecic zone will be recruited in the dermatology department of the St-Etienne University Hospital.

They will have biopsy, blood sample, examination of the scalp, questionnaire on sun exposure, Norwood scale, scinexa score, questionnaire of clinicals signs and questionnaire of the history of the hair loss.

Biopsy 4 to 5 mm from the distal part of the tips of the excision pieces. Three biopsies of 3 mm, made with punch, occipital hair zone (ZT) A completely painless sample, using a swab (soaked with a buffer solution) on the scalp of the ZH and ZT zone.

biopsy

Blood sample will be collected for performed for HIV serology, B and C hepatitis.

blood sample

Questionnaire on sun exposure will be completed by patients.

questionnaire on sun exposure

A complete examination of the scalp will be completed by dermatologist.

examination of the scalp

Norwood scale measure the evolution of baldness. It will be completed by dermatologist.

Norwood scale

Questionnaire of clinicals signs will be completed by dermatologist and patient.

questionnaire of clinicals signs

It's a assessment score of skin aging. It will be completed by dermatologist.

scinexa score

Questionnaire of the history of the hair loss will be completed by dermatologist and patient.

questionnaire of the history of the hair loss

JEAN LUC PERROT, MD

The aging of skin, especially that of the scalp, is a combination of intrinsic and extrinsic aging factors secondary to the chronic sun exposure. For men with an alopecia genetic (= bald men), the solar part, in skin aging process, is major.

The helio-dermal scalp is frequently the site of cancers mainly after 65 years. Objectives are to identify specific biomarkers involved in the photo-aging of the alopecic scalp

Investigators can also hope to understand and to explain the inter-individual inequality of the aging of skin. They can hope to a better understanding of the biological mechanisms between photo-induced skin aging and photo-induced carcinogenesis.

Investigators propose to study 40 male patients aged 65 and over in order to compare the state of aging of their scalp skin in the alopecic zone :

not hairy photo-exposed (= ZH sun damage zone) versus occipital hair zone protected photo (= ZT control zone).

Patients will be recruited in the dermatology department of the St-Etienne University Hospital who will benefit from the removal of a scalp tumour in the alopecic zone.

This study aims to identify biological markers, by transcriptomic analysis, associated with aging of the scalp, by comparing for each patient the skin of the scalp exposed to the light ("ZH") to an unexposed witness skin ("ZT").

The study will include :

* examinations to characterize components of the scalp: transcriptomic, proteomic and immunohistochemical analysis of skin biopsies, and a swab sampling will identify the cutaneous microflora of the scalp
* noninvasive examinations, in vivo

This is a prospective mono-centric study of the physiopathology of cutaneous aging.

Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old.

Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old. Mono-centric Prospective Study

Comparison of scalp skin biomarkers. It's compare cell differentiation, cell proliferation, cellular pigmentation, cell adhesion, cytoskeleton, aging and cellular senescence, extracellular matrix, antioxidant activity and inflammation.

The profile will be evaluated by relative quantification results of proteomic analyzes by a Shot-Gun Label-Free strategy.

Data will be examined by OCT examination (Optical Coherent Tomography): measuring the intensity of the dermis shine and the thickness of the epidermis.

Microflora will be evaluated by high-throughput sequencing (Illumina MiSeq) of the V1-V3 region of the ribosomal RNA (bacteria) and Internal Transcribed Spacer 1 (eukaryotes: yeasts) and evaluation of the amount of P. acnes of the scalp by quantitative RT-PCR of the lipase A gene.

This percentage will be evaluated by silicone casts

Skin aging is evaluated by histological examination: optical and biophotonic microscopy, semi-quantitative measurements of extracellular matrix markers such as collagens and elastin.

Heterogeneity of pigmentation will be measured using a numerical index (0 to 100) of heterogeneity, using data from dermatoscopic images.

The aging of the skin is evaluated by a semi-quantitative composite of 23 clinical variables : the scinexa score The global SCINEXA score (from 0 to 69. 0 = no skin aging and 69 = severe skin aging ) was obtained by adding the scores of each variable from 0 to 3.

0 = none, 1 = mild, 2 = moderate and 3 = severe.

ultrasound examination: measurement in mm of the thickness of the dermis and the hypodermis

examination in MCIV: measurement of the morphology of the dermal junction epidermis by semi-quantitative in vivo confocal microscopy

Solar exposure score : to assess in different periods

1. period of 10 to 17 years old
2. period of 18 to 40 years old
3. period of 41 to 60 years old
4. period since 61 years old

Each period contains same questions. Each item being rated in 5 answer choice from 1 to 5 (never, rarely, sometimes, often or very often) and two questions concern the zone where the patient live.

The Norwood Scale is a set of images that depict the different stages of male pattern hair loss.

The Norwood scale is composed of 12 images. Each image corresponds to one level. There is 7 levels (I , II, II A, III, III vertex, III A, IV, IVA, V, VA, VI, VII) Type I. Minimal hair loss. Type VII. The most severe form of hair loss. Little hair on the front or top of the head.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rational Therapeutics Based on Matched Tumor and Normal Tissue	NCT02272595	Advanced Cancer...	Treatment Based... Treatment Based...	18 Years -	M.D. Anderson Cancer Center
Rational Therapeutics Based on Matched Tumor and Normal Tissue	NCT02272595	Advanced Cancer...	Treatment Based... Treatment Based...	18 Years -	M.D. Anderson Cancer Center
Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old.	NCT03603587	Skin Aging Skin Cancer	biopsy blood sample questionnaire o... examination of ... Norwood scale questionnaire o... scinexa score questionnaire o...	65 Years -	Centre Hospitalier Universitaire de Saint Etienne
Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old.	NCT03603587	Skin Aging Skin Cancer	biopsy blood sample questionnaire o... examination of ... Norwood scale questionnaire o... scinexa score questionnaire o...	65 Years -	Centre Hospitalier Universitaire de Saint Etienne

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