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

Clinical trial: Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis

Summary: There are cells in the skin and blood of humans with chronic moderate to severe plaque psoriasis with specific activities that may determine the effectiveness of treatment. These activities may be described by obtaining samples of skin and blood and analyzing them using a variety of tests.

Detailed description: The final subject in Cohort 1 completed the study on 19-Nov-2013 (LSLV date). Because the study analyses were novel and exploratory, they required extensive analyses by study team and external experts. As a result of this analysis it was determined on 21-July-2014 that the data from Cohort 1 were sufficiently definitive and that enrollment of Cohort 2 would not be justified. Since this decision resulted in the LSLV for Cohort 1 becoming the LSLV for the study, the full data analysis and reporting is not projected to be complete within 12 Months of LSLV. The final analysis and final reporting is planned to be completed on 18-Feb-2015. Results for this data are anticipated to be released in April 2015.

Eligibility: Inclusion Criteria:
  -  Adults over 18 years of age with a diagnosis of chronic moderate to severe plaque psoriasis for at least 12 months; in generally good health; on stable dose of non-prohibited medications; able to stop current psoriasis therapy (systemic or topical) for several weeks prior to and during study participation.
  Exclusion Criteria:
  -  Serious underlying disease including viral disorders such as hepatitis or HIV or skin condition that would interfere with skin biopsies or evaluation of psoriasis; conditions that could interfere with drug absorption after oral administration; history of malignancy or auto-immune disease.
  -  Use of oral or injected corticosteroids (steroids).

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

Clinical trial: Preliminary Study of Sonic Hedgehog Signaling Pathway in the Pathogenesis of Rheumatoid Arthritis

Summary: Rheumatoid arthritis(RA) with a high incidence and high morbidity, the pathogenesis has not been fully elucidated. Fibroblast-like synovial cells excessive proliferation and synovial angiogenesis is the most important cause of RA synovitis and joint destruction. Our study was to find the role of Sonic Hedgehog(SHH) pathway in regulating proliferation of fibroblast-like synovial cells and modulating excess angiogenesis of synovial tissue.

Detailed description: 4ml blood from active RA patients(n=35) and healthy volunteers (n=35) will be collected
  -  peripheral blood mononuclear cells will be detached
  -  messenger ribonucleic acid expression of Sonic Hedgehog pathway associated factors in both groups will be detected
  Synovial tissues from 4 RA patients and 4 patients with traumatic or meniscal injury who need to carry out knee joint replacement operation will be collected
  -  inflammatory feature of synovial tissue will be observed
  -  the expression of Shh, Ptch1, Gli1 and Smo in synovial tissue will be detected by immunohistochemistry assay
  -  fibroblast-like synoviocytes will be cultured from synovial tissue of RA patients

Eligibility: Inclusion Criteria:
  -  definitely diagnosed
  -  the disease is active (DAS28>3.2)
  Exclusion Criteria:
  -  combined with severe organ dysfunction
  -  combined with other rheumatic diseases

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

Clinical trial: Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma

Summary: Patients with HNSCC represent a high-risk group for the development of SESCC. Thus, esophagogastrofibroscopy should be performed to detect possible synchronous esophageal carcinomas in these patients.
  Although only two patients with synchronous primary carcinomas were found among the patients with newly diagnosed HNSCC in this study, esophagoscopy and better some of advanced endoscopic methods should be recommended after detection of HNSCC to exclude secondary esophageal carcinoma or dysplasia. Staining of the esophagus with Lugol's solution is an easy and inexpensive option and can be done in most of gastroenterology offices.

Detailed description: ABSTRACT Objective: To evaluate the use of flexible esophagoscopy and chromoendoscopy with Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas) in patients with squamous cell carcinoma of the head and neck (HNSCC).
  Methods: All patients with newly diagnosed HNSCC underwent office-based Lugol chromoendoscopy. After flexible esophagoscopy with white light, 3.0% Lugol iodine solution was sprayed over the entire esophageal mucosa. Areas with less-intense staining (LVLs) were evaluated and biopsies taken.

Eligibility: Inclusion Criteria:
  -  Newly diagnosed patients with head and neck carcinoma
  -  Age 18-65
  Exclusion Criteria:
  -  Recurrent head and neck carcinomas
  -  Previously diagnosed oesophageal cancer

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

Clinical trial: Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

Summary: This pilot clinical trial studies arsenic trioxide in treating patients with basal cell carcinoma. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stop them from dividing

Detailed description: PRIMARY OBJECTIVES:
  I. To determine whether administration of arsenic trioxide (ATO) to patients with basal cell carcinoma is associated with a reduction in Gli messenger ribonucleic acid (mRNA) and protein levels in tumor biopsy samples, when compared to baseline levels.
  SECONDARY OBJECTIVES:
  I. To determine whether there is evidence of tumor size reduction of ATO against basal cell carcinoma in humans.
  OUTLINE:
  Patients receive arsenic trioxide intravenously (IV) over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility: Inclusion Criteria:
  -  Patients with basal cell carcinoma (BCC)
  -  Patients ineligible for curative locoregional treatment and have either progressed on, did not tolerate, unwilling to try or ineligible for investigational smoothened antagonist such as vismodegib (GDC 0449), XL 139 (BMS 833923), IPI- 926, LDE225 and PF-04449913
  -  Life expectancy estimate > 3 months
  -  Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
  -  Absolute neutrophil count >= 1,500/mcL
  -  Platelets >= 100,000/mcL
  -  Total bilirubin within normal institutional limits
  -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
  -  Creatinine within normal institutional limits
  -  Corrected QT interval (QTC) by 12 lead electrocardiogram (EKG) < 450 msecs
  -  Serum potassium within normal limits
  -  Magnesium within normal limits
  -  Calcium within normal limits
  -  Include the following: ability to understand and the willingness to sign a written informed consent document
  -  Patients must have evaluable tumor and be potentially eligible for pre and post ATO tumor biopsy
  Exclusion Criteria:
  -  Concurrent use of other Investigational agents is prohibited
  -  Patients with cardiac arrhythmias are excluded
  -  Patients receiving potassium wasting diuretics or amphotericin, while not excluded, must be noted to have theoretically increased arrhythmia risks with ATO
  -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recurrent seizure history or psychiatric illness/social situations that would limit compliance with study requirements
  -  Pregnant women and breastfeeding women are excluded from this study

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

Clinical trial: A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

Summary: This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in participants with multiple basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.


Eligibility: Inclusion Criteria:
  -  Adult participants, >/= 18 years of age
  -  Participants with multiple basal cell carcinomas, including participants with Gorlin syndrome, with at least 6 clinically evident basal cell carcinomas at the time of randomization, of which 3 measure 5 mm or more in diameter and are considered target lesions. All other lesions are considered to be non-target lesions
  -  Histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  -  Adequate renal and hepatic function and hematopoietic capacity
  -  Women of childbearing potential must agree to use contraception as defined by protocol during treatment and for at least 9 months after completion of study treatment
  -  Male participants with female partners of childbearing potential must agree to use contraception as defined by protocol during treatment and for 2 months after completion of study treatment
  Exclusion Criteria:
  -  Inability or unwillingness to swallow capsules
  -  Pregnant or breastfeeding women
  -  Any metastatic basal cell carcinoma
  -  Locally advanced basal cell carcinoma lesion that is considered to be inoperable or to have medical contraindications to surgery
  -  Recent (i.e., within the past 28 days prior to randomization) or current participation in another experimental drug study
  -  Known or suspected alcohol abuse
  -  One of the following known rare hereditary conditions: galactose intolerance, primary hypolactasia or glucose-galactose malabsorption

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

Clinical trial: Signet Ring Cell Carcinoma in Esophageal Adenocarcinoma

Summary: There has been much controversy surrounding the biologic behavior and prognosis of esophageal signet ring cell (SRCs) containing carcinomas. To clarify the biologic behavior of SRCs, the investigators compared the clinicopathologic features and prognosis of SRCs with other adenocarcinomas (ADC) of the esophagus and gastroesophageal junction (GEJ).

Detailed description: Adenocarcinoma (ADC) of the esophagus and gastroesophageal junction (GEJ) is an aggressive neoplasm and has a poor prognosis. Surgical based treatment has been the treatment of choice for localized esophageal adenocarcinoma.
  Signet-ring cell carcinoma is a unique histologic subtype of adenocarcinoma characterized by abundant intracellular mucin accumulation and a compressed nucleus displaced toward one extremity of the cell (the so-called signet-ring cell (SRC)). According to the World Health Organisation (WHO), a true signet-ring cell carcinoma (SRCca) is defined as an adenocarcinoma in which the predominant component (more than 50% of the tumor) consists of isolated or small groups of SRC in the stroma. If the tumor contains less than 50% of those cells, it is generally considered as an adenocarcinoma (ADC).

Eligibility: Inclusion Criteria:
  - Adenocarcinoma R0 resection Primary surgery
  Exclusion Criteria:
  - Other histology R1 or R2 resection Neoadjuvant therapy

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

Clinical trial: A Study of Vismodegib With Surgery in Patients With Previously Untreated Basal Cell Carcinoma

Summary: This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in patients with basal cell carcinoma. Patients will be randomized to receive oral daily doses of vismodegib 150 mg or matching placebo. The anticipated time on study drug treatment is 12 weeks.


Eligibility: Inclusion Criteria:
  -  Adult patients, >=18 years of age
  -  Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
  -  Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
  -  Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements
  Exclusion Criteria:
  -  Prior treatment with vismodegib
  -  Known hypersensitivity to any of the study drug excipients
  -  Any metastatic basal cell carcinoma
  -  Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
  -  Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
  -  Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
  -  Recent, current, or planned participation in another experimental drug study

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

Clinical trial: Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Head and Neck Basal Cell Carcinomas

Summary: The purpose of this study is to determine the narrowest excision margin for head and neck Basal Cell Carcinoma (BCC) tumors satisfying the National Comprehensive Cancer Network® (NCCN) low-risk for recurrence clinical and histopathological criteria that gives an acceptable (95%) clinical cure-rate over a 3 year follow-up period. Margins of 1 and 2mm are evaluated.

Detailed description: Basal Cell Carcinoma (BCC) is the most common skin cancer in the US. Most are treated by surgical excision. Excision margins vary by tumor size, anatomic location, histological subtype, and surgeon preference. Published recommendations and follow up observation times vary. Current clinical practice supports the 4 mm excision margin; however, this can be a disservice to the patient by potentially excising additional normal tissue unnecessarily and yielding larger scars. Considering healthcare costs, both the excision and repair components are usually billed by size measurements. Determining the narrowest excision margin to give an acceptable clinical cure could feasibly reduce this expenditure.

Eligibility: Inclusion Criteria:
  -  Patient has a BCC <10mm on their cheeks, forehead, scalp & neck or <6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular & postauricular, temple & ear
  -  The BCC has well defined borders
  -  The BCC is primary
  -  The Patient is not immunosuppressed
  -  The BCC is not located at a site of prior radiation therapy
  -  The histologic subtype is nodular or superficial
  -  There is no perineural involvement
  Exclusion Criteria:
  -  Patient has a BCC >or=10mm on their cheeks, forehead, scalp & neck or >or=6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular & postauricular, temple & ear
  -  The BCC has poorly defined borders
  -  The BCC is recurrent
  -  The Patient is immunosuppressed
  -  The BCC is located at a site of prior radiation therapy
  -  The histologic subtype is aggressive
  -  There is perineural involvement

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

Clinical trial: Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer During Radiation or Chemoradiation Therapy

Summary: The impact of sonifilan on the quality of life in patients with cervical cancer during radiation or chemoradiation therapy
  1. Primary endpoint : Quality of life
  2. Secondary endpoint : complications related to Sonifilan, treatment effect of Sonifilan

Detailed description: Study design Prospective randomized controlled trial
  Study period Protocol registration approval date - may/31/2016
  Study drug Sonifilan(Sizofiran)
  Study population
  1. Cervical cancer FIGO stage IA2-IVA patients will be participated.
  2. Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma
  3. age 20-75 year
  Treatment Fron the day of radiation therapy started, Sonifilan 20mg, 1amp IM/week for 8weeks
  Concurrent therapy Chemo & radiation therapy
  1. Cisplatin 40mg/m2, day 1, 8, 15, 2, 29, 36
  2. External whole pelvic irradiation 3000-3500 cGy / 6 fractions in high dose rate
  Assessment
  1. Pre-study assessment (within 4weeks before participation) a medical history b informed consent c ID number assignment d life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI e basic information collect
  2. On-study assessment (during study) a complication check b life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI
  3. Post-study assessment (1week after study finished) a MRI b PAP smear c HPV test d life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI
  4 Follow-up assessment (every 3 month for 1 year) a Pelvic exam b PAP smear c HPV test d MRI (if needed) e PET (if needed) f life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI 93, 6, 12, 24 month after study finished)

Eligibility: Inclusion Criteria:
  -  Cervical cancer FIGO stage IA2 - IVA
  -  Histologic type : SCC, Adenocarcinoma, Adenosquamous carcinoma
  -  GOG performance status 0-2
  Exclusion Criteria:
  -  past radiation therapy history
  -  Neuroendocrine carcinoma
  -  concurrent other cancer
  -  uncontrolled medical disease
  -  ulcerative disease history
  -  current pregnancy and lactation

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

Clinical trial: Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response

Summary: In this phase I pilot study, it is planned to investigate the feasibility and safety of adding an interferon therapy to an preexisting imatinib treatment in patients with chronic phase chronic myeloid leukaemia. The participating patients have already reached a response during their imatinib therapy (CCyR) but have still a detectable disease (no molecular response MR 4.5 or better).


Eligibility: Inclusion Criteria:
  -  Patients ≥ 18 years of age
  -  BCR-ABL positive chronic myeloid leukaemia in chronic phase treated with imatinib as first line therapy
  -  CHR, CCyR after at least 18 months of imatinib treatment
  -  Adequate organ function, defined as the following:
  -  total bilirubin < 1.5 x ULN,
  -  AST and ALT < 2.5 x ULN,
  -  creatinine < 1.5 x ULN,
  -  ANC > 1.5 x 109/L,
  -  platelets > 100 x 109/L
  -  Written, voluntarily signed informed consent
  Exclusion Criteria:
  -  CMR (molecular remission 4.5 or BCR-ABL transcripts undetectable)
  -  Patient has received any other investigational treatment within 28 days before study entry
  -  Treatment with a second generation tyrosine kinase inhibitor (dasatinib, nilotinib)
  -  ECOG performance status ≥ 3
  -  Patients with a primary of a different histological origin than the study indication (unless relapse-free interval is ≥ 5 years, except cervical carcinoma, basal cell epithelioma or squamous cell carcinoma of the skin)
  -  Evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease etc.)
  -  Acute chronic infections
  -  Known autoimmune disease (e.g. collagen disease, polyarthritis, immune thrombocytopenia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder)
  -  Female patients who are pregnant or breast-feeding
  -  Known diagnosis of HIV

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

Clinical trial: Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas

Summary: The p63 gene is a recently discovered member of the p53 family located at chromosome 3q27Many studies have reported that overexpression of p63 can mimic p53 activities by binding DNA, activating transcription, and inducing apoptosis.
  Various studies proved p63 as a marker of basal cells in normal salivary glands, breast, prostate, respiratory and squamous epithelia, and of tumor cells from various malignancies. Still, p63 has been the subject of relatively few studies in lung adenocarcinoma, and breast carcinoma, and no study has described the correlation of p63 with pancreatic ductal adenocarcinoma.
  In the current study, we aim to evaluate the prognostic value of the expression of p63 in the lung adenocarcinoma, breast adenocarcinoma, and pancreatic ductal adenocarcinoma. We will achieve this aim by collecting clinical data retrospectively from the patients' medical records as well as assessing the histological sections and performing immunohistochemical staining for p63.


Eligibility: Inclusion Criteria:
  -  Patients who were treated at our institution for lung adenocarcinoma, breast adenocarcinoma, or pancreatic ductal adenocarcinoma.
  -  Available histopathological diagnosis of the malignancy.
  Exclusion Criteria:
  -  Patients with inoperable tumors.
  -  Patients with second primary tumor.
  -  Patients with pathological blocks not enough for future slicing.

Relevance to patient case: not relevant