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

Clinical trial: Checking Wether the m-ALA Cream Could Mark Correctly the Borders of BCC's Tumors

Summary: Correlation between Mohs surgery and microscopic fluorescence photometry in determination of histological borders in Basal Cell Carcinoma .

Detailed description: Background: Basal Cell Carcinoma (BCC) is the most common form of nonmelanoma skin cancer worldwide. BCCs are slow-growing, locally invasive tumors that rarely metastasize but can cause extensive morbidity through local tissue destruction. Recurrence is often the consequence of incomplete removal of the cancer tissue. Mohs' micrographic surgery is considered the most effective treatment modality for BCC with a recurrence rate of less than 5 %, however, the technique requires specialized training and is labor-intensive and costly. Fluorescence imaging by topical application of a tumor-localizing agent such as methyl 5-aminolevulinic acid (MAL), resulting in buildup of photosensitizing porphyrin IX (PpIX) that can be visualized by Woods' light fluorescence, might serve as a quick and simple "bed-side" technique for demarcation of BCC tumor borders prior to surgical excision Objective: To test the reliability of MAL-induced porphyrin fluorescence tumor demarcation by comparison with the tumor borders determined by Mohs' surgery Methods: Twenty eight patients with facial BCCs (17 nodular, 3 superficial, 1 morphea type, 3 ulcerated and 4 recurrent tumors) scheduled for Mohs' surgery were recruited for the study. The night before the surgical procedure, crusts were gently removed and an approximately 1 mm thick layer of a cream containing 16 % MAL (MetvixR) was applied to the tumor area as well as to the surrounding skin and covered by a transparent occlusive dressing. The following morning (10-17 hours after MetvixR application), the dressing was removed, and the lesion size was determined with a caliber by measuring the largest perpendicular diameters under natural (clinical size) and Woods' (fluorescence size) illumination. The patients then underwent the scheduled Mohs' surgical procedure, and the tumor size (Mohs' size) was determined when reaching the tumor free margins.

Eligibility: Inclusion Criteria:
  -  A- bove 18 years
  Exclusion Criteria:
  -  Childern
  -  Pregnant women

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

Clinical trial: A Pilot Study of the Treatment of Facial Nodular and Nodulocystic Basal Cell Carcinoma With Double Curettage and Cautery Followed by Application of Imiquimod to the Base

Summary: The purpose of this study is to determine recurrence rates of nodular Basal Cell Carcinomas on the face removed with curettage and electrodessication (cautery) followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with curettage and electrodessication alone.

Detailed description: Basal Cell Carcinomas (BCC) are the commonest form of skin cancer in the white population. The face is where they most frequently occur and the nodular BCCs are the commonest type. Curettage and cautery/electrodessication (C&C) has been an established way of management of nodular BCCs for years, being a simple surgical procedure readily performed in outpatient clinics with good aesthetic results and high cure rates. The purpose of this study is to determine recurrence rates of nodular BCCs on the face removed with C&C followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with C&C alone. Imiquimod is an immune response modifier with anti-tumour effects already licensed for the treatment of superficial BCCs in the UK.

Eligibility: Inclusion Criteria:
  -  Well-defined primary, not previously treated nodulo-cystic BCC
  -  Size of the lesions: ≤ 1cm diameter
  -  Facial lesions
  -  Patient compliance competent
  -  Patient physically able to apply the treatment (cream)
  Exclusion Criteria:
  -  Recurrent lesions
  -  Superficial, morphoeic or pigmented BCC
  -  Lesions close to vital structures; i.e. where C&C is not considered a standard treatment (eyelids, inner canthus, free borders)
  -  Lesions within 1 cm of the eyelids, nose, lips and hairline
  -  Immunosuppressed patients
  -  Women in childbearing age, pregnancy and breast-feeding
  -  Ages <50 or >90
  -  Patients compliance incompetent
  -  Patients physically incapable to apply the treatment (cream)
  -  Patients with Gorlin Syndrome (nevoid Basal Cell Carcinoma syndrome)

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

Clinical trial: A Biological Sample Collection Protocol of Women With and Without Breast Cancer

Summary: The purpose of this trial is to collect plasma, serum, whole blood and tissue samples from women with breast cancer and plasma, serum, whole blood from healthy women, which will be made available to researchers for biomarker analysis.

Detailed description: OUTLINE: This is a multi-center study.
  The treatment plan for each breast cancer subject will be determined at the discretion of the treating physician and subject. This protocol does not prescribe any particular standard of care treatment.
  There will be no treatment for the healthy volunteers.

Eligibility: Inclusion Criteria:
  FOR WOMEN WITH BREAST CANCER
  -  Histologically or cytologically confirmed invasive malignancy or ductal carcinoma in situ of the breast.
  -  Preparing to begin a new regimen for breast cancer (adjuvant, locally recurrent, any line metastatic).
  -  Female.
  -  Age > 18 years at the time of consent.
  -  Written informed consent and HIPAA authorization for release of personal health information.
  FOR HEALTHY VOLUNTEERS
  -  No known history of invasive malignancy or ductal carcinoma in situ. Volunteers must not have prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled as healthy volunteers.
  -  Female
  -  Age > 18 years at the time of consent.
  -  Written informed consent and HIPAA authorization for release of personal health information.
  Exclusion Criteria:
  -  Females must not be pregnant.

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

Clinical trial: Etanercept Plus UVB-311nm Phototherapy in Psoriasis

Summary: Etanercept, a biological antipsoriatic drug with anti-tumor-necrosis factor (TNF) activity has been approved for the treatment of moderate to severe psoriasis. However, in a substantial portion of cases etanercept does not induce reduction in psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study the researchers aim to determine in a randomized half-side comparison, whether additional narrowband UVB-311nm phototherapy accelerates and improves the therapeutic efficacy of etanercept.

Detailed description: Patients with moderate to severe psoriasis who have received a standard dose of etanercept (50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or greater qualify for the study. Etanercept is continued and UVB-311nm phototherapy is added at 6 weeks or thereafter on a randomized body half (left or right; head exempt) 3 x per week until complete response (defined as reduction in PASI to < 3) for a maximum of another 6 weeks (until week 12). PASI score and patient disease score is assessed weekly; patient life quality score at week 0, 6, and 12; all scores at follow-up visits at month 3, 6, and 12. Paired statistical testing (T-test or Wilcoxon) for differences in PASI and patient disease and life quality scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction > 90%, > 75%, and/or 50% between body sites.

Eligibility: Inclusion Criteria:
  -  Patients with moderate to severe psoriasis who have received a standard dose of etanercept (50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or greater
  Exclusion Criteria:
  -  Pregnancy or lactation
  -  Presence of or history of malignant skin tumors
  -  Dysplastic melanocytic nevus syndrome
  -  Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
  -  Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
  -  Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
  -  General poor health status

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

Clinical trial: Use of an SPF30 Sunscreen and an After-sun-lotion in Skin Cancer Risk Patients

Summary: Study aim: To determine the effect of an intensified daily photoprotection over 24 months with an SPF30 sunscreen and an after sun-lotion both containing liposomal DNA repair enzymes in a population of patients at high-risk for skin cancer, including xeroderma pigmentosum (XP) and basal cell nevus syndrome.

Detailed description: An SPF 30 sunscreen and a proprietary after sun lotion both containing a combination of plankton extract and micrococcus lysate (kindly provided by ATEIA AG, Vaduz, Liechtenstein) was used in a pilot study of intensified photoprotection in patients with multiple skin cancers. Thirteen patients (8 women and 5 men), between 37 and 81 years old, who had had a history of multiple skin cancers were enrolled in the study. Five of the patients had xeroderma pigmentosum (XP) (complementation group: A, 2; C,1; and non-classified 2); one patient XP variant, 3 patients basal cell nevus syndrome, and four patients no skin cancer syndrome. Patients were instructed to apply their sunscreen regularly before sun exposure and 4.5 ml of the after sun lotion to their face and arms daily, as close to mid-day as possible for a period of up to 24 months. The patients were examined in 3-month intervals and the new appearance of actinic keratoses and skin cancers was recorded. New lesions were removed at these visits and the pathology was confirmed by histological examination, except in the cases of (multiple) actinic keratoses, whenever patients agreed. The number of skin tumors during the 24 months of the study was compared to the number in the preceding 24 month-period before study entry. The data were obtained from patient charts and/or electronic files. There was a statistical trend for less BCCs during the study period compared to the prestudy period. In addition, the patients received at each of the 3-month visits a questionnaire and were asked to rate the status of their skin on face and arms during the last 3 months for various parameters on a scale from -2 (maximum worsening) to +2 (maximum improvement). The patients' ratings revealed a statistically significant improvement for several parameters: smoothness, color spots, wrinkles, burning, irritation, teleangiectasia, infections, warts, and skin lesions or sores, starting as early than at the first 3-month visit with a maximum effect seen at 12 months. No adverse effects were noted during the study.

Eligibility: Inclusion Criteria:
  -  Xeroderma pigmentosum
  -  Basal cell nevus syndrome
  -  Other patient with a history of multiple skin cancers (three or more lesions, including actinic keratosis, squamous cell carcinoma, basal cell carcinoma, and/or malignant melanoma)
  Exclusion Criteria:
  -  Intolerance of study preparation
  -  Allergy against study preparation
  -  Non-acceptable side effects

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

Clinical trial: Radiation Therapy During Surgery in Treating Older Women With Stage I Breast Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving intraoperative radiation therapy may reduce the amount of normal tissue that needs to be removed.
  PURPOSE: This phase II trial is studying how well giving radiation therapy during surgery works in treating older women with stage I breast cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Study the feasibility and reproducibility of intraoperative radiotherapy as the only treatment after lumpectomy in older women with stage I breast cancer.
  Secondary
  -  Study the impact of this regimen on maintaining self-care.
  -  Study the quality of life (QLQ-C30) and satisfaction with care.
  -  Study regimen tolerance and cosmetic results.
  -  Evaluate the economic impact of this treatment.
  -  Study relapse-free and disease-specific survival.
  OUTLINE: Patients undergo conservative breast surgery and axillary node dissection (sentinel node or classic resection). At this point, patients must have either negative axillary lymph nodes after removal of ≥ 6 lymph nodes, negative sentinel nodes, or have had a limited lumpectomy with negative margins ≥ 2 mm. Patients undergo intraoperative radiotherapy during surgery, before closing and reconstruction of the breast.
  Patients may begin hormonal therapy after completing study therapy.
  After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Eligibility: DISEASE CHARACTERISTICS:
  Inclusion criteria:
  -  Histologically confirmed stage I breast cancer
  -  Size ≤ 20 mm (by ultrasound), N0, any quadrant
  -  Hormone receptor status not specified
  Exclusion criteria:
  -  Distant metastases
  -  Inflammatory breast cancer
  -  Lobular in situ disease
  -  Invasive cancer or ductal carcinoma in situ
  -  Nonepithelial disease or sarcoma
  -  Multicentric disease
  -  Lymphatic embolism
  -  Margins of safety unknown or positive (in situ or invasive)
  -  Preoperative mammography showing diffuse microcalcification
  PATIENT CHARACTERISTICS:
  -  Female
  -  Menopausal
  -  Karnofsky 70-100%
  -  No other prior cancer except basal cell skin cancer, uterine epithelioma in situ, or other cancer in complete remission for the past 5 years
  -  No geographic, social, or psychiatric reasons that would impede participation in study treatment
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior neoadjuvant therapy
  -  No concurrent participation in another study

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

Clinical trial: A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma

Summary: We have compared to types of surgery to assess which one leaves the smaller surgical defect.

Detailed description: Patients with a clinical diagnosis of a nodular basal cell carcinoma of less than 1 centimetre and 1 centimetre away from eyes, nose and ears were either randomized to undergo Mohs Micrographic Surgery or standard surgical excision. After the tumour had been removed the defect was measured.

Eligibility: Inclusion Criteria:
  -  Subjects with a clinical diagnosis of a nodular basal cell carcinoma of less than 1 cm, 1 cm away from eye, nose or ears
  Exclusion Criteria:
  -  Subjects of less than 18 years of age
  -  Subjects unable to comply with instructions,
  -  Immunosuppressed subjects

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

Clinical trial: Intron-A/Aldara Combination Therapy for Basal Cell Carcinoma (BCC)

Summary: A trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara.


Eligibility: Inclusion Criteria:
  -  Nodular or superficial basal cell carcinoma on the skin excluding scalp or face
  Exclusion Criteria:
  -  Pregnancy

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

Clinical trial: Long-term Extension From RCC Phase II (11515)

Summary: Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).


Eligibility: Inclusion Criteria:
  Patients are classified into two groups as below at transition date from Study 11515 to this study.
  Population I: Patients who are willing to continue the study drug, for whom the investigator consider continuation of the study drug is appropriate, and who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515.
  Population II: Patients who have been monitored only for survival status at the end of Study 11515.
  Population 1
  1. Patients who are willing to continue the study drug,
  2. Patients for whom the investigator consider continuation of the study drug is appropriate
  3. Patients who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515.
  4. Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  Population 2
  1. Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  Exclusion Criteria:
  1. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  2. Any condition that could jeopardize the safety of the patient or that affect his/her compliance in the study
  3. Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate birth control.

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

Clinical trial: Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

Summary: The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite in facial photodamage in a randomized double blind trial.

Detailed description: It has been demonstrated that photodamage leads to wrinkles, mottled pigmentation, lentigines, telangiectasias, and textural changes, but more importantly, it can also lead to pre-cancerous conditions with the development of actinic keratosis (AK). The majority of photorejuvenation or photodamaged published studies have used 5-Amino-Levulinic acid (5-ALA) as a photosensitizer, and either a blue light or an Intense Pulsed Light source with a 70%-95% global facial skin improvement. The molecular mechanism of such improvement is unknown, but activation of a non-specific immune response in addition to increased fibrosis and new collagen formation, have both been suggested.
  Methyl Aminolevulinate ( MAL) is another marketed photosensitizer mainly utilized in Europe. Lipophilicity, higher penetration depth and tumor selectivity has been advocated for MAL compared to 5-ALA. However, its effect in photodamaged skin has not been well documented.
  The aim of the study is to determine the efficacy of MAL + Aktilite (PDT) in facial photodamage.
  Study Type: Interventional
  Study Design: Randomized, double-Blind, placebo-controlled trial. Official Title: A randomized, double-Blind, placebo-controlled trial of Methyl Aminolevulinate + Aktilite in patients with facial photodamage.

Eligibility: Inclusion Criteria:
  -  Female subjects older than 35 years of age and less than 75 years of age
  -  Subjects with a photodamage grade of 2 or 3 according to a modified Dover´s Global photodamage scale
  -  Subjects willing to participate according to protocol requirements.
  -  Patients with signed Informed Consent
  -  Patients with no exclusion criteria
  Exclusion Criteria:
  -  Pregnant or nursing females.
  -  Subjects with suspected porphyria, Systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug induced photosensitization.
  -  Any active infectious skin disorder ( Herpes simplex, molluscum contagiosum, facial warts )
  -  Subjects with less than 6 months of previous rejuvenation interfering treatments
  -  Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments.

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

Clinical trial: A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma

Summary: This multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer.

Detailed description: Esophageal cancer is one of the most frequent causes of cancer death in the world. The most common type of esophageal cancer is squamous cell carcinoma (SCC) in China. Although concurrent radiochemotherapy is recommended as the standard treatment for advanced esophageal carcinoma, the local failure still reaches up to 44%-54%.
  Sodium Glycididazole(CMNa) is a radiosensitive drug for hypoxic tumor cells. Clinical trials showed that CMNa can improve local control rate and survival rate of esophageal cancer. This study is going to confirm the efficacy and safety of CMNa in concurrent radiochemotherapy of radiotherapy and 5-FU+DDP for esophageal squamous carcinoma.

Eligibility: Inclusion Criteria:
  -  written informed consent
  -  photographically and histologically proven thoracic esophageal squamous carcinoma
  -  stages 2a-3, and stage 4 with only supraclavicular lymph nodes metastasis defined by AJCC(2002)
  -  radiochemotherapy indication
  -  measurable tumor
  -  adequate hematologic, hepatic and renal function
  -  Karnofsky performance status ≥70
  -  age more than 18years and less than 70 years
  Exclusion Criteria:
  -  pregnancy and lactation
  -  significant neurologic disease
  -  severe liver and renal malfunction,and Significant medical illness
  -  previous chemotherapy, radiotherapy or immunotherapy
  -  esophagus hemorrhage and esophagus perforation features

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

Clinical trial: A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer

Summary: The purpose of this study is to determine the safety of BMS-833923 (XL139) in patients with advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule


Eligibility: For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
  Inclusion Criteria:
  -  Advanced or metastatic cancer (excluding cancer in the blood) or uncontrolled basal cell nevoid syndrome or sporadic basal cell carcinoma
  -  Primary or metastatic tumor site accessible for biopsy
  -  Ability to swallow capsules
  -  Subjects with histologically confirmed, advanced stage IIIB or stage IV non-small cell lung cancer (NSCLC) with a primary histology of squamous carcinoma who have received prior systemic therapy for advanced NSCLC will be enrolled in Part 3
  Exclusion Criteria:
  -  Uncontrolled brain metastasis
  -  Significant cardiovascular disease
  -  Inadequate blood counts
  -  Inadequate liver, kidney or lung function
  -  Gastrointestinal disease within last 3 months
  -  Infection with Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C or exposure to attenuated active immunizations

Relevance to patient case: not relevant