araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Study of Use of CTC in NSCLC

Summary: The purpose of this study is to assess whether the detection of circulating tumor cells (CTC) could be used as a tool to earlier diagnose, more accurately predict treatment response / failure and predict overall survival in non-small cell lung cancer (NSCLC) patients

Detailed description: Lung cancer remains the most common cause of cancer mortality in the world for both men and women. More than half of patients diagnosed will die within the first year. Given these concerning facts, we are in need of novel methodologies to diagnose patients at earlier stages of the disease, more accurately predict treatment response / failure and predict overall survival.
  The use of CTC has been investigated and shown to predict progression free survival and overall survival in metastatic breast cancer, and recommended as a breast cancer tumor marker by the American Society of Clinical Oncology. There have also been relationships between CTC's and survival, shown in metastatic colorectal and prostate cancer. However, CTC's have not been thoroughly investigated in non-small cell lung cancer. This trial will assess if the detection of circulating tumor cells could be used as a tool to help further advance treatment for NSCLC patients.

Eligibility: Inclusion Criteria:
  For subjects with lung malignancies:
  -  18 years of age and older
  -  Diagnosis of new or recurrent non-small cell lung cancer
  -  Awaiting treatment and follow up
  -  Have radiographic measurable metastatic disease that can be followed
  -  Be able to sign an IRB approved informed consent form
  -  Life expectancy greater than 12 weeks
  For subjects with COPD and without lung malignancies:
  -  18 years of age and older
  -  Diagnosis of COPD
  -  No current or prior malignancies (except squamous or basal cell carcinoma of the skin)
  -  Be able to sign an IRB approved informed consent form
  For Healthy Control Subjects (Dry Runs):
  -  18 years of age and older
  -  Has no current or prior malignancies (except squamous or basal cell carcinoma of the skin)
  -  Patients must sign an IRB approved informed consent form
  Exclusion Criteria:
  For subjects with lung malignancies:
  -  Have other concurrent lung cancer malignancies, or any other form of malignancy (except squamous or basal cell carcinoma of the skin)
  -  ECOG performance status of 4
  -  Pregnant female (self-reporting)
  -  Cognitively Impaired
  -  Prisoner
  For subjects with COPD and without lung malignancies and Healthy Controls:
  -  Any other form of malignancy (except squamous or basal cell carcinoma of the skin)
  -  Pregnant female (self reporting)
  -  Cognitively impaired
  -  Prisoner

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: LDE225 for Patients With PTCH1 or SMO Mutated Tumors

Summary: The purpose of this signal seeking study is to determine whether treatment with LDE225 demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic malignancies to warrant further study


Eligibility: Inclusion Criteria:
  -  Patient has confirmed diagnosis of a select solid tumor (except medulloblastoma, basal cell carcinoma and pancreatic adenocarcinoma) or hematological malignancy (except CML, ALL and AML).
  -  Patient has pre-identified tumor with a PTCH1 or SMO mutation.
  -  Patient has received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
  -  Patient has progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.
  -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  Exclusion Criteria:
  -  Patients has received prior treatment with LDE225.
  -  Patients has neuromuscular disorders associated with elevated CK (i.e. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis
  -  Patients has primary CNS tumor or CNS tumor involvement
  -  Patient has received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug

Relevance to patient case: possibly relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Study of BMS-833923 in Two Specific Patients With Basal Cell Nevus Syndrome

Summary: This is an extension study of Protocol CA194002 to allow 2 specific participants with basal cell nevus syndrome in the CA194002 study at Princess Margaret Cancer Centre who are still benefitting from the study drug BMS-833923 to continue receiving the study drug. This study will continue to evaluate the safety and tolerability of BMS-833923 in these participants.

Detailed description: The purpose of this study is to evaluate the safety and tolerability of BMS-833923 administered on an extension protocol in subjects with basal cell nevus syndrome (BCNS). This is an extension study of Protocol CA194002 to allow 2 specific participants with BCNS in the CA194002 study at Princess Margaret Cancer Centre who are still benefitting from the study drug BMS-833923, to continue receiving the study drug. In this open-label extension protocol, no new subjects will be recruited. The two BCNS subjects from Protocol CA194002 (subjects CA194002-1-14 and CA194002-1-25) will continue to receive BMS-833923 at the dose and schedule administered on CA194002 until fulfilling protocol criteria for discontinuation. These patients are receiving different doses: one being 60mg once every 2 weeks, and the other is receiving 300mg once daily. This study will continue to evaluate the safety and tolerability of BMS-833923 in these participants.

Eligibility: Inclusion Criteria:
  -  Signed consent
  -  Two specific study participants enrolled on protocol CA194002 at Princess Margaret Cancer Centre and remain on BMS-833923 at the time of study entry
  -  Women, age 18 years and above
  -  Agree to use methods to prevent pregnancy, not pregnant or breastfeeding
  Exclusion Criteria:
  -  Known symptomatic brain metastasis
  -  A serious uncontrolled medical disorder or active infection, which would impair the ability of the patient to receive protocol therapy
  -  Gastrointestinal disease or surgery that could impact the absorption of study drug
  -  Inability to swallow oral medication
  -  Inability to be venipunctured and/or tolerate venous access
  -  Uncontrolled or significant cardiovascular
  -  Any other medical, psychiatric and/or social reason
  -  Have HIV, HepB, or HepC
  -  Exposure to immunosuppressants and immunotherapy concurrently with study treatment and up to 3 months
  -  Acceptable physical and laboratory test findings
  -  History of allergy to compounds chemically-related

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Topical Itraconazole in the Treatment of Basal Cell Carcinoma

Summary: This research is being done to study the molecular effects of topically applied itraconazole ointment on the growth of basal cell carcinomas.

Detailed description: Basal cell carcinoma is the most common type of skin cancer in Caucasians worldwide. Although rarely metastatic, it can be locally destructive causing disfigurement and pain. Current therapies include surgical removal, local destruction, radiotherapy and others.
  Advances in understanding the molecular basis behind BCCs indicate that mutations in the hedgehog signaling pathway can lead to the development of many sporadically occurring BCCs. An oral drug that targets the hedgehog signaling pathway has been shown to be effective in treating patients with metastatic and inoperable BCCs. There is evidence that itraconazole, a commonly prescribed antifungal medication may also affect this pathway. It is not known whether itraconazole ointment applied topically can affect the growth of BCCs.

Eligibility: Inclusion Criteria:
  -  Participants must be over the age of 18 years
  -  Male
  -  Women who do not have child-bearing potential (history of hysterectomy, post-menopausal)
  -  Have a biopsy confirmed BCC that measures at least 6mm in size at the time of the initial evaluation (visit #1);
  -  Participant must be willing and comply with the requirements of the protocol;
  -  Participant must have the ability to understand and communicate with the investigator;
  -  Participant must provide informed consent.
  Exclusion Criteria:
  -  Subject with significant congestive heart failure (CHF) or history of CHF, chronic renal failure, hepatic failure, neuropathy
  -  Subject with current skin diseases that the investigator feels is not safe for study participation including but not limited to severe atopic dermatitis, cutaneous T-cell lymphoma, erythroderma;
  -  Subjects on systemic medications known to affect the Hedgehog pathway (see Appendix I)
  -  Subjects on cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, methadone, levacetylmethadol (levomethadyl), lovastatin, simvastatin, dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine), cisapride, pimozide, methadone, levacetylmethadol (levomethadyl), quinidine
  -  Subjects with history of hypersensitivity to azoles
  -  Subjects with Gorlin syndrome
  -  Subjects on chronic immunosuppression, or who have a history of compromised immune function (e.g. history of or current malignancy other than BCC/squamous cell skin cancers)
  -  Subjects who do not speak English or have difficulty hearing or are otherwise impaired for providing informed consent and communicating with the investigator;
  -  Subjects with a history of keloids or excessive scarring;
  -  Subjects with known allergy to lidocaine, epinephrine, itraconazole or petrolatum
  -  Women of child-bearing age/potential and/or able to conceive

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

Summary: Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking due to inconsistent design of available studies. The purpose of this study is to evaluate the PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low risk anatomical sites in an evidence based study setting.


Eligibility: Inclusion Criteria:
  -  histologically confirmed unpigmented sBCC on the trunk and extremities
  -  maximal tumour diameter 30 mm
  Exclusion Criteria:
  -  Fitzpatrick skin type >III
  -  pregnancy
  -  previous BCC treatment within 4 weeks
  -  coagulation disorders
  -  photo sensitizing medication
  -  any indication of poor compliance

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Ovarian Clear Cell Adenocarcinoma Review

Summary: Clear cell carcinoma comprises 5-10% of surface epithelial ovarian cancers, and about 30-40% of the patients with clear cell carcinoma are diagnosed in the advanced stage. The investigators studied the response to chemotherapy and survival for either paclitaxel-platinum based chemotherapy or conventional platinum-based chemotherapy among all stages clear cell ovarian carcinoma. Prognostic factors for survival among the patients with pure, advanced, clear cell ovarian carcinoma were also evaluated.

Detailed description: 1. Several authors have reported frequent admixtures of clear cell ovarian carcinoma with serous, mucinous, and endometrioid tumors. However, few papers addressed the difference in response to chemotherapy and survival between patients with pure and mixed-type advanced clear cell carcinoma.
  2. Recent trends in the clinical management of advanced ovarian cancer include increased attention to maximal cytoreduction and general acceptance of paclitaxel-platinum-based adjuvant chemotherapy.
  3. The introduction of paclitaxel markedly changed the postoperative management of ovarian cancer patients, but the results and value of these newer efforts and therapies applied to clear cell carcinoma are as yet undetermined.
  4. Today, paclitaxel-platinum-based chemotherapy is becoming the standard regimen for ovarian cancer worldwide. Previous research suggests a potential benefit of paclitaxel plus carboplatin regimens for stage I clear cell carcinoma. However, few papers specifically addressed the efficacy of paclitaxel-platinum-based chemotherapy for advanced clear cell carcinoma because clear cell carcinoma occurs only rarely in Western countries.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of Ovarian clear cell carcinoma
  Exclusion Criteria:
  -  not undergo operation

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma

Summary: The purpose of this study is to assess the effectiveness of electronic skin surface brachytherapy (ESSB) for early stage basal or squamous cell carcinoma of the skin using a new device. This new device is Nucletron's Esteya Electronic Skin Surface Brachytherapy System. The investigators want to understand what effects, good and/or bad this device for delivering brachytherapy has on your skin cancer. The investigators also want to assess the safety, cosmetic results, the effects that ESSB has on quality of life and to correlate skin imaging with clinical response to ESSB.


Eligibility: Inclusion Criteria:
  -  Men or women ≥ 60 years old with estimated life expectancy of ≥ 5 years
  -  Histopathologic diagnosis of basal or squamous cell carcinoma
  -  Clinical stage T1N0M0 (by AJCC 2010 criteria)
  °Basal cell carcinoma with morpheaform, sclerosing, mixed, infiltrative or micronodular features must be ≤1 cm
  -  Low risk pathologic features (by AJCC 2010 criteria)
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix C)
  -  Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English)
  -  Ability to provide informed consent
  Exclusion Criteria:
  -  BCC/SCC that was previously treated (ie, recurrent BCC/SCC)
  -  BCC/SCC in region adjacent to or overlapping with region of prior radiotherapy
  -  BCC/SCC on irregular surface (ie, target area not flat)
  -  BCC/SCC adjacent to or overlapping with burn or scar
  -  BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow)
  -  BCC/SCC in area with compromised lymphatic drainage or vascular supply
  -  BCC/SCC within 3 cm of another treated or untreated BCC/SCC
  -  Inflammatory process in target area
  -  Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis)
  -  Diabetes that is poorly controlled
  -  Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans)
  -  Receipt of treatment with another investigational device or drug
  -  Receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector)
  -  High likelihood of protocol non-compliance (in opinion of investigator)

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Confrontation Phenotypes and Genotypes of Epithelial Odontogenic Tumors of the Jaws

Summary: Systematically compare the phenotype and genotype of epithelial odontogenic tumors in children and adults with a clinical, radiographic, pathologic and molecular level.
  Either:
  establish an observatory of this multidisciplinary tumor establish a tumor bank annotated scale unparalleled testing pathophysiological hypotheses search for prognostic factors.

Detailed description: This is an observational study with retrospective and prospective parts. In retrospective part be included the Patients followed between 1992 and January 2011.
  In prospective part will follow the Patients will be included after the starting of study.
  There are 2 centers :
  1. st center is in the service of Stomatology and Maxillofacial Surgery in the Pitie Salpetriere Hospital.
  2. nd center is in the service of Maxillofacial Surgery in hospital Armand Trousseau.
  Number of patients include in the part retrospective :
  Center N°1-300adults Center N°2-90childrens
  Number of patients include in the part prospective :
  Center N°1- 90 Center N°2- 30
  Duration of study is 3 years Duration of inclusion is 32 months Each patient will be followed for 4 months and for further up to 3 years from the first patient included.
  We envision a next circuit : obtaining consent, preoperative consultation,surgery, postoperative consultation N°1, postoperative consultation N°2, genetics consultation and monitoring of patients in 6;12;18;24 months from surgery of tumor and limited in 3 years from th 1st patient included.

Eligibility: Inclusion criteria
  1. Patient with an osteolytic lesion of the jaws
  2. Patient with epithelial odontogenic tumor:
  keratocysts ameloblastoma Pindborg tumor or calcifying (ESWT) Epidermoid (Squamous Odontogenic Tumor SOT) Clear cell (Clear Odontogenic Tumor Cells CCOT)
  3. Patient monitoring in the period 1992 to January 2011 at the Trousseau Hospital (children) or at the Pitie Salpetriere (adult)
  4. Patient aged 5 years or more
  5. Adult patient who had signed informed consent
  6. Holders of parental authority of minor patient were informed and signed consent
  Non inclusion criteria
  1. Patient with an osteolytic lesion of dental origin inflammatory (adjacent teeth decayed, non-living mortified)
  2. Patient with a cyst fissure (nasopalatine, symphyseal or globulomaxillary)
  3. Patient with arteriovenous malformation, vascular
  4. Patient with cons-indication to MRI
  5. Patient not affiliated with a social security scheme (beneficiary or assignee)
  6. Pregnant woman
  7. Patient in his history of hypersensitivity to salts of gadolinium
  8. Patient receiving a measure of legal protection

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM

Summary: Primary Objective:
  To demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2 diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300.
  Secondary Objectives:
  To assess in a 4-week once-daily dosing regimen with HOE901-U300 in pen-naïve and insulin-naïve T2DM patients.
  The safety and usability of the U300 pen injector. The glycemic control with the U300 pen injector. The safety of HOE901-U300.

Detailed description: The total study duration for a participants can be approximately up to 10 weeks.

Eligibility: Inclusion criteria:
  -  Patients with T2DM inadequately controlled with non-insulin, non-injectable anti-hyperglycemic drug(s) and for whom the Investigator/treating physicians has decided that basal insulin is appropriate.
  -  Signed written informed consent.
  Exclusion criteria:
  -  Glycated hemoglobin A1c (HbA1c) <7.0% (<53 mmol/mol) or >11% (97 mmol/mol) at screening.
  -  Age <18 years at the time of screening.
  -  Body Mass Index (BMI) >40 kg/m2.
  -  Diabetes other than T2DM.
  -  History of T2DM for less than 1 year before screening.
  -  Less than 6 months anti-hyperglycemic treatment before screening.
  -  Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
  -  Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonist.
  -  Patients receiving only non-insulin anti-hyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides.
  -  Current or previous insulin use except for a maximum of 8 consecutive days and a total of 14 days (eg, acute illness, surgery) during the last year prior to screening.
  -  Any contraindication to insulin glargine (Lantus) according to the National Product labeling or any excipients.
  -  Any contraindication to the mandatory background non-insulin anti-hyperglycemic medication according to the respective National Product labeling.
  -  Latest eye examination by an ophthalmologist >12 months prior to inclusion.
  -  More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
  -  Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period.
  The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Autologous Platelet-Rich Plasma Cream for Photoaging and Chronological Skin Aging

Summary: Human skin undergoes some morphological changes with the effects of chronological aging and photoaging, these are especially remarkable in the facial skin. Changes in pigmentation, sallowness, deep wrinkling, laxity and elastosis are the main changes seen in photoaging and chronologic aging of skin. With the increasing demand, it needs to provide new approach for the prevention and treatment of these morphological changes.
  Fibroblasts have a key role on skin aging. It is known that platelet rich plasma activates the fibroblasts and increases the synthesis of collagen and other type of matrix components. Because of these specialities, platelet rich plasma is thought to be effective on skin aging.

Detailed description: Clinical evaluation of the patients will be done for five times during 3 months. 0th day (Basal), 7th day, 15th day, 45th day and 105th day.

Eligibility: Inclusion Criteria:
  -  The patient has periorbital wrinkles with Glogau Scale 3 or more
  Exclusion Criteria:
  -  Patients with precancerous lesions
  -  Patients with inflammatory skin disease like rosacea, psoriasis, seborrheic eczema
  -  Patients with connective tissue disease like lupus erythematosus
  -  Patients have a cosmetic intervention to their face, like chemical peel, infrared, radio frequency, laser, fillers or botulinum toxin injections in last 6 months
  -  Patients who use an anti aging cream containing retinoic acid, vitamin C and peptides in last 3 months
  -  Pregnant or lactating females

Relevance to patient case: not relevant