araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC

Summary: Objective: To investigate the incidence of lateral neck node occult metastasis and to show the usefulness of sentinel lymph node biopsy (SLNB) in the detection of lateral neck node metastasis in thyroid carcinoma, the investigators used a radioisotope to detect the sentinel lymph node.
  Summary Background Data: Although occult lymph node metastasis to the lateral neck compartment is common in papillary thyroid carcinoma, the incidence and patterns of lateral neck node metastasis in papillary carcinoma are not known.

Detailed description: On the day of the operation, patients underwent preoperative lymphoscintigraphy after the intratumoral injection of a Tc-99m phytate 1 mCi in 0.1-0.2 mL 0.9% NaCl under ultrasonographic guidance. Total thyroidectomy or lobectomy with central neck dissection preceded SLN detection to avoid interference by primary tumor radioactivity. After total thyroidectomy or lobectomy, the dissections were performed toward the internal jugular chain beneath the sternocleidomastoid muscle. A handheld, collimated gamma probe and lymphoscintigraphy were used to scan the lateral compartments (through skin and under the SCM) for "radioactive" lymph nodes. Removed SLNs were submitted immediately for frozen biopsy. If any of the SLNs were positive for metastasis on the frozen sections, MRND was performed immediately. In cases for which the frozen section was negative but the final pathology report detailed microscopic positivity in the lateral sentinel nodes, RAI ablations were performed without additional MRND.

Eligibility: Inclusion Criteria:
  -  Cases with tumors larger than 1 cm in size or with suspicious central neck node metastasis in Papillary thyroid cancer
  Exclusion Criteria:
  -  The patient with definite metastatic lymph node in lateral neck compartment

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

Summary: Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study. The investigators started this study from May of 2009 and this study will be continued until Dec. 2011.

Detailed description: The investigators will assign all patients to three groups; no dissection group (Group I), sentinel lymph node biopsy only group (Group II) and routine central neck dissection group (Group III). At first, to know the necessity of routine central neck node dissection for micro PTC,the investigators will compare the result of group I and group III. Additionally, the investigators can analyze the usefulness of sentinel lymph node biopsy for substitution of routine central neck node dissection for micro PTC.

Eligibility: Inclusion Criteria:
  -  papillary carcinoma of thyroid (less than 4cm)
  -  no evidence of lymph node metastasis in preoperative work-up result
  -  the patients who accept this study
  Exclusion Criteria:
  -  large thyroid cancer( > 4cm)
  -  morbid
  -  anticoagulation agent usage
  -  endoscopic or robotic thyroid operation
  -  evidence of lymph node metastasis or extrathyroidal extension in preoperative US and CT scan

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients

Summary: Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons for early discontinuation.

Detailed description: This study was terminated on 01-Aug-2011 due to very low potential to enroll planned number of patients or any sufficient number of patients for complete statistical analyses. This study is not being terminated because of safety or efficacy concerns.

Eligibility: Inclusion Criteria:
  -  Postmenopausal females.
  -  Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
  -  Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
  -  Patients whose tumour was estrogen receptor positive (ER+).
  -  Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
  Exclusion Criteria:
  -  Patients for whom Aromasin® treatment is contraindicated (see SPC).
  -  Presence of metastasis or a contra lateral tumour.
  -  Other adjuvant endocrine therapy.
  -  Another concomitant antineoplastic treatment.
  -  Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

Summary: RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
  PURPOSE: This phase II trial is studying how well everolimus works in treating patients with locally advanced or metastatic thyroid cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To evaluate response rate in patients with locally advanced or metastatic, unresectable or refractory thyroid cancer treated with everolimus.
  Secondary
  -  To evaluate overall survival of these patients treated with everolimus.
  -  To evaluate progression-free survival of these patients.
  -  To evaluate toxicity of this therapy in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
  Blood samples are collected periodically for correlative studies.
  After completion of study treatment, patients are followed up for 12 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed thyroid cancer
  -  Progressive or refractory disease within the past 6 months
  -  Locally advanced or metastatic disease
  -  Measurable disease, defined as ≥ 1 measurable lesion defined by RECIST criteria
  -  Not amenable to surgical resection or external-beam radiotherapy or refractory to radioiodine therapy
  -  No untreated brain metastasis
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  Life expectancy > 3 months
  -  ANC ≥ 1,500/mm³
  -  Platelet count ≥ 100,000/mm³
  -  Hemoglobin ≥ 9.0 g/dL
  -  Creatinine < 1.5 mg/dL
  -  Total bilirubin ≤ 1.0 times upper limit of normal (ULN)
  -  ALT and AST ≤ 3.0 times ULN
  -  No known hypersensitivity to the study drug
  -  No serious uncontrolled systemic intercurrent illness (e.g., infection or poorly controlled diabetes)
  -  No history of significant neurological or mental disorder, including seizures or dementia
  -  No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin
  -  No active uncontrolled cardiac disease
  -  No myocardial infarction within the past 12 months
  -  Able to take oral medication
  -  No active peptic ulcer disease
  -  Must have patient compliance and geographic proximity for adequate follow-up
  PRIOR CONCURRENT THERAPY:
  -  At least 30 days since prior mTor-inhibitor therapy (e.g., temsirolimus) or non-hormonal anticancer therapy
  -  At least 2 weeks since prior and no concurrent P-glycoprotein, CYP3A4, and CYP3A5 inhibitors or inducers
  -  No prior surgical procedure affecting absorption
  -  No other concurrent systemic chemotherapy, investigational drug, or radiotherapy

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

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: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment

Summary: The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib


Eligibility: Inclusion Criteria:
  -  Provision of informed consent prior to any study specific procedures
  -  Female or male aged 18 years and over
  -  Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Documentation must be provided in patient's medical chart
  -  WHO or ECOG Performance status 0-2
  -  Negative pregnancy test (urine or serum) for female patients of childbearing potential
  Exclusion Criteria:
  -  Unstable brain metastases or spinal cord compression that require treatment, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
  -  Major surgery within 4 weeks before randomization
  -  The last dose of prior chemotherapy received less than 3 weeks prior to randomization
  -  Radiation therapy not completed prior to the first dose of vandetanib
  -  Significant cardiac event, superior vena cava syndrome, NYHA classification of heart disease ≥2, within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases risk of ventricular arrhythmia
  -  Creatinine clearance <30 ml/min (calculated by Cockcroft-Gault formula),Patients with moderate renal impairment, defined as creatinine clearance ≥30 to <50 ml/min, must start vandetanib at a reduced dose of 200 mg

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: A Study of TRK-170 for the Treatment of Crohn's Disease

Summary: In Crohn's Disease Patients
  -  To evaluate the efficacy of TRK-170
  -  To evaluate the PK characteristics of TRK-170
  -  To assess the safety of TRK-170


Eligibility: Inclusion Criteria:
  -  Patient has a diagnosis of Crohn's Disease before screening
  -  Patient has stable disease activity
  Exclusion Criteria:
  -  Patient has had a clinically significant illness prior to screening
  -  Patient with clinically significant deviations in laboratory values

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

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: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

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: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

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: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Summary: The purpose of this study is to determine whether prophylactic central neck dissection is beneficial for patients with papillary thyroid cancer staged preoperatively as node negative.

Detailed description: Several respected organizations have recently recommended that total thyroidectomy plus prophylactic central neck dissection should be the standard operation for papillary thyroid cancer. However, it is still unclear if this approach has any benefit on survival or locoregional control of the disease. In addition, potential advantages of this more aggressive surgical approach should outweigh the risk of morbidity. The purpose of this retrospective cohort study is to determine whether prophylactic central neck dissection is beneficial for patients with papillary thyroid cancer staged preoperatively as node negative. In this study outcomes of total thyroidectomy versus this plus prophylactic central neck dissection for papillary thyroid cancer are compared in a 10-year follow-up. Patients operated between 1993 and 1997 (n=282) underwent total thyroidectomy alone, whereas patients operated between 1998 and 2002 (n=358) underwent total thyroidectomy plus prophylactic central neck dissection.

Eligibility: Inclusion Criteria:
  -  a pathological diagnosis of papillary thyroid cancer,
  -  in a patient with negative cervical lymph nodes on pre-, or intraoperative evaluation
  Exclusion Criteria:
  -  incidental diagnosis of papillary thyroid cancer following hemithyroidectomy and requiring completion thyroidectomy,
  -  one-stage lymph nodes dissection based on therapeutic intent,
  -  previous thyroid surgery,
  -  incomplete follow-up information,
  -  incomplete histopathology report,
  -  ASA grade higher than 3 (American Society of Anesthesiology)

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)

Summary: This study is conducted in the United States of America (USA). The aim of the study is to monitor the number of annual new cases of medullary thyroid carcinoma (MTC) and to establish a registry for these new cases in order to identify any possible increase related to the introduction of liraglutide, exenatide once-weekly, and other GLP-1 receptor agonists into the US market.

Detailed description: This active surveillance program will monitor for any signal indicating a possible association between treatment with long-acting GLP-1 RAs and the development of MTC in the United States population. Given the very low incidence of MTC in the general population, the expected rate of exposure to long-acting GLP-1 RAs, the anticipated long latency of the potential outcome under study and the limited data on underlying risk factors for development of MTC other than RET proto-oncogene mutations, an active surveillance program is the most efficient means of identifying a possible association between MTC and products in the long-acting GLP-1 RAs class. Given the uncertainty of the association of MTC in humans treated with these drugs, a study duration of at least fifteen years from the time of market introduction of the first long-acting GLP-1 RA was thought to provide evidence of an association, if one exists. If such an association is identified, a case-control study will be initiated to quantify the association.
  The MTC registry is a Food and Drug Administration (FDA) post-marketing requirement for long-acting GLP-1 RA products. Because of the rarity of MTC and in order to minimize inconvenience to patients, physicians, and state cancer registries, FDA encouraged sponsors of long-acting GLP-1 RAs to work collaboratively to conduct this registry. Consequently, the MTC Registry Consortium has been formed for this purpose.
  The MTC Registry Consortium refers to the Sponsors with approved long-acting GLP-1 RAs who have a contractual agreement to participate in the MTC Registry.
  This active surveillance program for cases of MTC will be conducted with assistance from the North American Association of Central Cancer Registries (NAACCR). NAACCR is a collaborative umbrella organization for cancer registries, government agencies, professional organizations, and private groups in North America interested in improving the quality and use of cancer registry data. All of the central cancer registries in the U.S. and Canada are members of NAACCR, including those that participate in SEER.

Eligibility: Inclusion Criteria:
  -  A record of medullary thyroid carcinoma (MTC) identified from state/regional population-based cancer registries
  -  At least 18 years or older.
  There are no other inclusion or exclusion criteria.

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Leptin Levels in Papillary Thyroid Cancer

Summary: The purpose of this study is to evaluate Leptin levels in females, in the setting of papillary thyroid cancer, benign thyroid nodules, and in normal females without thyroid disease.

Detailed description: There will be three groups in this study, but 2 of the groups are part of another study so will only recruit normal controls.

Eligibility: Inclusion Criteria:
  -  Female
  -  Age>/- 19
  -  Not currently pregnant or lactating
  -  Normal thyroid gland by history
  Exclusion Criteria:
  -  Male Gender
  -  Pregnancy
  -  Lactation
  -  Age below 19
  -  Abnormal thyroid gland by history
  -  Abnormal thyroid gland by structure using ultrasound
  -  Abnormal thyroid gland by function using TSH, Free T4

Relevance to patient case: not relevant