araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 40-year-old female with thyroid cancer; genetic feature: BRAF

Clinical trial: A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation

Summary: This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC) positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Adult participants. >/= 18 years of age
  -  Histologically confirmed metastatic or unresectable papillary thyroid cancer for which standard curative or palliative measures do not exist or are no longer effective; participants whose tumors exhibit areas of "other histology" may be enrolled, provided the tumor histology remains predominantly papillary
  -  Positive for BRAF V600 mutation (Roche Cobas 4800 BRAF V600 Mutation Test)
  -  Radioactive Iodine resistant disease
  -  Prior therapy excluding (Cohort 1, TKI Naive) or including (Cohort 2, TKI Experienced) TKI
  -  Clinically relevant disease progression according to RECIST criteria within the prior 14 months
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  -  Adequate hematological, renal and liver function
  Exclusion Criteria:
  -  Histological diagnosis other than papillary PTC, including squamous cell variants of PTC or PTC with areas of squamous metaplasia
  -  Active or untreated central nervous system metastases
  -  History of or known carcinomatous meningitis
  -  Anticipated or ongoing administration of any anti-cancer therapies other than those administered in the study
  -  Active squamous cell skin cancer that has not been excised or adequately healed post excision
  -  Previous treatment with any agent that specifically and selectively targets the MEK or BRAF pathway
  -  Prior radiotherapy to the only measurable lesion
  -  Clinically relevant cardio-vascular disease or event within the prior 6 months

Relevance to patient case: definitely relevant
Patient case: 40-year-old female with thyroid cancer; genetic feature: BRAF

Clinical trial: Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia

Summary: Fentanyl is expected to suppress tracheal tube-induced cough during emergence from general anaesthesia through binding to its receptors in the brainstem. However, it has not been proven if fentanyl has a complication-free, dose-dependent effect on cough suppression during emergence from sevoflurane anaesthesia. The purpose of this study is to evaluate the relationship between fentanyl doses and cough suppression during emergence from sevoflurane anaesthesia.


Eligibility: Inclusion Criteria:
  -  the patients undergoing general anaesthesia for elective thyroidectomy due to thyroid neoplasm.
  -  ASA I-II.
  -  20-59 years old.
  -  female only.
  Exclusion Criteria:
  -  signs of difficult intubation.
  -  risks for perioperative pulmonary aspiration.
  -  history of chronic respiratory disease.
  -  recent upper respiratory track infection.
  -  previous and recent smoking history

Relevance to patient case: not relevant
Patient case: 40-year-old female with thyroid cancer; genetic feature: BRAF

Clinical trial: A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases

Summary: This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma [except treatment with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase (MEK) inhibitors]. Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.


Eligibility: Inclusion Criteria:
  -  Adult participants, >/= 18 years of age
  -  Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test)
  -  Measurable brain metastases, defined as lesions that were accurately measured in at least one dimension (longest diameter to be recorded) as ≥0.5 cm in the brain MRI with contrast, treated or untreated
  -  Participants may or may not have received prior systemic therapy for metastatic melanoma and either a) have received no prior treatment for brain metastases or b) have received prior treatment for brain metastases and have progressed
  -  Participants may or may not have symptoms related to their brain metastases
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  -  Participants must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma
  Exclusion Criteria:
  -  Increasing corticosteroid dose during the 7 days prior to first dose of study drug
  -  Leptomeningeal involvement in participants with no prior treatment for brain metastases
  -  Previous malignancy requiring active treatment within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix
  -  Concurrent administration of any anticancer therapies other than those administered in the study
  -  Treatment with any cytotoxic, investigational drug or targeted therapy 4 weeks prior to first dose of study drug. Radiation therapy ≤1 week prior to first administration of vemurafenib; and stereotactic radiotherapy ≤1 day prior to prior to first administration of vemurafenib
  -  Prior treatment with BRAF or MEK inhibitors
  -  Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug

Relevance to patient case: not relevant
Patient case: 40-year-old female with thyroid cancer; genetic feature: BRAF

Clinical trial: Genetic Expression Alteration Affect on Lateral Neck Node Metastasis of Thyroid Papillary Microcarcinoma : Microarray Analysis

Summary: In this study, the investigators look at the genetic expressional alteration which influenced on the early lateral neck node metastasis in thyroid papillary microcarcinoma.

Detailed description: Papillary thyroid carcinomas (PTCs) measuring 1.0 cm or less in diameter were defined as papillary thyroid microcarcinomas (PTMCs) by the World Health Organization (WHO), emphasizing on their benign behavior, probably of little clinical significance, which do not affect patients' survival. However, some reported that PTMCs may have aggressive behavior, can cause locoregional recurrences, cervical lymph node metastases, and even distant metastases. But till now, the characteristics of PTMCs with early lateral neck node metastasis were only reviewed and described by the clinicopathological parameters, and no analysis of PTMCs by the gene level is available. In these study, we investigate the genetic expressional alteration which influenced on the early lateral neck node metastasis in thyroid papillary microcarcinoma.

Eligibility: Inclusion Criteria:
  -  age≥20 years old
  -  Conventional type papillary thyroid microcarcinoma (0.5cm≤tumor size≤1.0cm)
  -  group 1: no lymph node metastasis /group 2: with lateral neck node metastasis
  Exclusion Criteria:
  -  tumor with capsular invasion (T3 tumor)
  -  distant metastasis
  -  combined underlying thyroiditis

Relevance to patient case: not relevant
Patient case: 40-year-old female with thyroid cancer; genetic feature: BRAF

Clinical trial: Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer

Summary: Metastases of thyroid cancer with iodine uptake are treated with repeated activity of I-131 administered after thyroid hormone withdrawal. The goal of thyroid hormone withdrawal is to treat patients with elevated thyrotropin stimulated hormone (TSH), a hormone secreted by the pituitary, a gland just located under the brain. Another way to obtain elevated TSH levels is to perform intramuscular injection of recombinant human TSH, a hormone produced pharmaceutically. The goal of this study is to know whether the radioiodine uptake by the metastases is similar after rhTSH administration or after thyroid hormone withdrawal.

Detailed description: Patients will undergo a rhTSH stimulation, staying on thyroid hormone treatment. Following 2 administration of rhTSH an injection of I-124 will be performed. Positron emission tomography with computed tomography scans (PET/CT), blood tests, and measurements of whole body radioactivity will occurred during the 4 to 96 hours following I-124 administration in order to perform dosimetry (i.e.) to estimate the radiation dose delivered to the metastases. After 4 weeks under thyroid hormones patients will undergo thyroid hormone withdrawal and a new administration of I-124 will be performed. The same dosimetry study will be realized with PET/CT, blood tests, and measurements of whole body radioactivity. A therapeutic activity of I-131will then be administered followed by whole body scan realized 24 to 72 hours after the administration of I-131. Dosimetry studies will be compared in order to determine whether rhTSH stimulation can replace thyroid hormone withdrawal for the treatment of distant metastases.

Eligibility: Inclusion Criteria:
  1. Patients with thyroid cancer and known measurable (>1cm) distant metastases demonstrating radioiodine uptake on a previous whole body scan
  2. Patients planned for a therapeutic activity of 131I after thyroid hormone withdrawal
  3. Age >18 years
  4. Previous treatment with radioiodine more than 6 months before inclusion.
  5. Serum TSH level <0.5 mU/L
  6. Normal renal function with a creatinine clearance estimation using the Cockcroft-Gault formula > 60 ml/ml
  7. Effective means of contraception for female patient, at risk of pregnancy
  8. Written informed consent
  Exclusion Criteria:
  1. Patients whose majority of tumoral lesions disclose FDG uptake without radioactive iodine uptake
  2. Iodine excess (< 50 μg/dl)
  3. Large or diffuse bone or brain metastases
  4. Patients with multiple small tumor foci less than 1 cm in diameter, such as miliary spread to the lungs
  5. Patients already included in a therapeutic trial with an experimental medicine
  6. Pregnancy and breast feeding patients
  7. Subject with any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
  8. Treatment with antivitamin k

Relevance to patient case: not relevant
Patient case: 40-year-old female with thyroid cancer; genetic feature: BRAF

Clinical trial: BRAF V600E Mutations In Papillary Thyroid Carcinoma

Summary: The purpose of this study is to determine whether BRAF V600E mutation in our patients with papillary thyroid cancer has an association with poor prognosis.

Detailed description: Papillary thyroid carcinoma (PTC) is the most common type of thyroid malignancy and BRAF V600E mutation is the most common genetic alteration identified in PTC, ranging from 25 to 80%, with the average rate about 45%. Various studies demonstrated a relationship between BRAF V600E mutation and aggressive characteristics of the cancer, including the worse patient prognosis. But,there are no studies from Turkey regarding this topic. So the investigators will examine BRAF V600E mutation in our patients with PTC and try to assess the role of this mutation in prognosis and further management of the patients.

Eligibility: Inclusion Criteria:
  -  Patients with papillary thyroid cancer
  Exclusion Criteria:
  -  Patients who do not want to be a part of this study

Relevance to patient case: definitely relevant
Patient case: 40-year-old female with thyroid cancer; genetic feature: BRAF

Clinical trial: Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm

Summary: This protocol will evaluate microRNA biomarkers in blood and fine-needle aspirate biopsies (FNAB) of thyroid nodules. MicroRNA profiles will be determined and evaluated for their utility in pre-operative diagnosis, in particular to distinguish benign from malignant throid neoplasms. Post-surgical fresh-frozen thyroid cancer tissue will be assessed for somatic mutations, mRNA, and microRNA expression patterns. FFPE tissue will be used to obtain H&E and unstained slides to specific biomarker results using immunohistochemistry.

Detailed description: This protocol requires the collection of blood (5 ml), fine-needle aspirate biopsies (FNAB), and post-surgical thyroid cancer tissue. The post surgical tissue includes fresh-frozen tissue that is considered waste and in excess of that required for pathologic diagnosis, and archived formalin-fixed, paraffin-embedded tissue (FFPE). The blood will be used as a substrate for assessing known markers, including microRNA expression patterns that may be useful to predict disease and thyroid cancer morphotype. The FNABs will be used to screen the potential of markers for pre-operative diagnosis. The post-surgical fresh-frozen thyroid cancer tissue will be used to isolate DNA and RNA in order to assess somatic mutations (RAS and PAX8/PPAR-gamma rearrangement) and messenger RNA, and microRNA expression patterns. The FFPE tissue will be used to obtain H&E and unstained slides to validate results using immunohistochemistry. The goal of these studies is to define molecular markers that will accurately distinguish benign from malignant disease and the multiple thyroid cancer phenotypes. Current methods of distinguishing benign from malignant disease requires a detailed post-surgical analysis and no known markers have yet been identified to reliably differentiate the multiple thyroid cancer morphotypes.

Eligibility: Inclusion Criteria:
  -  Patient with palpable thyroid nodule suspicious for thyroid neoplasm
  -  Patient selected to undergo fine needle biopsy for cytologic diagnosis
  -  Male (18 years of age or older)
  -  Female (18 years of age or older)

Relevance to patient case: not relevant
Patient case: 40-year-old female with thyroid cancer; genetic feature: BRAF

Clinical trial: A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma

Summary: CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.


Eligibility: Inclusion Criteria:
  For the dose escalation phase:
  1. Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]). For the dose expansion phase: (i) Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]), or (ii) confirmed diagnosis and non-resectable advanced metastatic colorectal cancer (mCRC) for which no further effective standard therapy exists.
  2. Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation.
  3. Evidence of measurable disease
  Exclusion Criteria:
  1. Previous therapy with a MEK inhibitor.
  2. Symptomatic or untreated leptomeningeal disease.
  3. Symptomatic or untreated brain metastasis.Patients previously treated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enroll. Brain metastasis must be stable with verification by imaging.
  4. Known acute or chronic pancreatitis.
  5. Clinically significant cardiac disease
  6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818
  7. Previous or concurrent malignancy. Exceptions to this exclusion criteria include: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
  8. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
  9. History of thromboembolic or cerebrovascular events within the last 6 months
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 40-year-old female with thyroid cancer; genetic feature: BRAF

Clinical trial: To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer

Summary: The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.

Detailed description: An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease

Eligibility: Inclusion Criteria:
  -  Written consent from Female or male patients aged 18 years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous 14 months prior to enrolment, and/or
  -  Have one or more symptoms that the Investigator believes to be related to the patient's MTC.
  -  World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
  -  Has measurable disease (at least one lesion, not irradiated within 12 weeks of study randomisation, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).
  -  Lesions must be amenable to accurate and repeat measurement.
  Exclusion Criteria:
  -  Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization.
  -  Abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 2.5xULRR or 5.0xULRR if related to liver metastases).
  -  Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than 450 ms.
  -  Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
  -  For women only - currently pregnant or breast feeding.

Relevance to patient case: not relevant
Patient case: 40-year-old female with thyroid cancer; genetic feature: BRAF

Clinical trial: A Study of Zelboraf (Vemurafenib) in Patients With BRAF V600 Mutation-Positive Cancers

Summary: This open-label, multi-center study will assess the efficacy and safety of Zelboraf (vemurafenib) in patients with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom Zelboraf is deemed the best treatment option in the opinion of the investigator. Patients will receive twice daily oral doses of 960 mg Zelboraf until disease progression, unacceptable toxicity, or withdrawal of consent.
  The safety and efficacy of Zelboraf in combination with cetuximab in a subset of patients with colorectal cancer will also be assessed.


Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  -  Must have recovered from all side effects of their most recent systemic or local treatment
  -  Adequate hematological, renal and liver function
  For solid tumors only:
  -  Histologically confirmed cancers (excluding melanoma and papillary thyroid cancer) with a BRAF V600 mutation and that are resistant to standard therapy or for which standard or curative therapy does not exist
  -  Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
  For multiple myeloma only:
  -  Confirmed diagnosis of multiple myeloma with a BRAF V600 mutation
  -  Patients must have received at least one prior systemic therapy for the treatment of multiple myeloma
  -  Patients treated with local radiotherapy
  -  Patients must have relapsed and/or refractory multiple myeloma with measurable disease
  Exclusion Criteria:
  -  Melanoma, papillary thyroid cancer or hematological malignancies (with the exception of multiple myeloma)
  -  Uncontrolled concurrent malignancy
  -  For patients with multiple myeloma: solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
  -  Active or untreated CNS metastases
  -  History of or known carcinomatous meningitis
  -  Concurrent administration of any anti-cancer therapies other than those administered in this study
  -  Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that would, in the investigator's opinion, contraindicate participation in this study

Relevance to patient case: not relevant