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

Clinical trial: Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer

Summary: Medullary thyroid carcinoma (MTC) is a rare tumor arising from C cells of the thyroid gland and belonging to the endocrine tumors. 18F-DOPA PET, based on tha capacity of endocrine tumor cells to take-up, decarboxylate and store amino-acids, such 3-4-dihydroxyphenylalanine(DOPA), is used for imaging endocrine tumors. The aim of the study was to evaluate the contribution of 18F-DOPA whole-body PET for the detection of recurrences in patients with proven recurrent MTC without evidence of recurrence or metastases on several imaging modalities.

Detailed description: In patients MTC and persistently elevated calcitonin levels, the challenge is finding the site of residual disease. Since the only satisfying treatment is surgery, the early detection and precise location is important. Tumor localization techniques usually performed, including ultrasonography of the neck and liver, chest and abdomen, bone scintigraphy, isotopic scanning and even PET with FDG are poorly sensitive. The use of 18F-DOPA may be more sensitive and specific engineering for localization metastatic disease. The study include 100 patient with persistent MTC demonstrated by elevated tumor markers (calcitonin and CEA) and no evidence of recurrence on morphological imaging procedures. 18F-DOPA whole-body PET is performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA, the patient fasted for 6 hours prior the start of the examination.
  All 18F-DOPA PET are evaluated independently by two experienced nuclear medicine physicians and any tracer accumulation exceeding the normal uptake tissue is rated as pathologic finding. The sensibility and efficiency of 18F-DOPA PET will be analysed and Malignant tissue confirmed by histology after surgery or biopsy or by follow-up for one year.

Eligibility: Inclusion criteria:
  -  Patients up to 18 years old with medullary thyroid cancer / carcinoma
  -  Patients with medullary thyroid cancer / carcinoma recurrence, which have a high calcitonin level / rate, more than 100pg/ml, associated - or not - to a high CEA (Carcinoembryonic Antibodies) level / rate, dated from less than 3 months
  -  Patients with a less than 3 months conventional imaging checkup (cervical ultrasonography, cervical-chest-abdomen tomography and / or magnetic resonance imaging, abdomen ultrasonography, osseous / bones radionuclide imaging), in which the tumor site not certainty located
  -  Informed Consent Form signed and dated by patients
  -  Patients which are "SECURITE SOCIALE" affiliated
  Exclusion criteria:
  -  Pregnant or suckling women
  -  Women able to procreate, without efficient birth control
  -  Patients already included in another Nuclear Medicine or Imaging research protocol using ionizing radiations; the efficient dose accumulation will not exceed 20 mSv.

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

Clinical trial: Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma

Summary: One of the most effective treatments for metastases from thyroid cancer is a form of radioactive iodine known as 131-I. For more than 50 years, 131-I has been used to find and destroy thyroid cancer cells that have spread to other parts of the body. In many cases this treatment destroys the metastatic cells. However, in some patients it does not appear to work completely. This study is designed to use a slightly different form of radioactive iodine (called 124-I) which can precisely predict the amount of radiation that each metastatic lesion will receive.
  124-I was developed at Memorial Sloan-Kettering in the 1950s and has been used here and at many other medical centers around the world for diagnostic studies. It has been found to be very safe and effective at finding metastatic lesions. The high resolution of newer PET scanners now allows us to carefully determine how much radiation each metastatic lesion will receive. If 124-I can accurately predict which patients will not respond to 131-I treatments we can then avoid exposing those patients to unnecessary radiation. For the rest of the patients we can custom tailor the 131-I dose to destroy the metastatic lesions.


Eligibility: Inclusion Criteria:
  -  Adult thyroid carcinoma patients who have had a total thyroidectomy, histology confirmed by an MSKCC attending pathologist, and radioiodine remnant ablation.
  -  Adult thyroid carcinoma patients who have previously demonstrated radioiodine-avid metastases and are about to undergo Thyrogen-assisted dosimetry at MSKCC.
  -  The patient and physician are planning to administer 131-I for therapy if persistent radioiodine-avid metastases are present.
  -  Men and women of all races, ethnicities, and religious backgrounds are eligible.
  -  All subjects must have measurable disease, documented within the previous six months by ultrasonography (US), MRI, or non-contrast CT scanning.
  Exclusion Criteria:
  -  Thyroid cancer patients who do not have metastases.
  -  Thyroid cancer patients who have not demonstrated that their metastases concentrate radioiodine.
  -  Patients who are under therapy for other active cancers.
  -  Anaplastic or Medullary thyroid carcinoma.
  -  Age less than 18 years.
  -  Patient who have received a therapeutic dose of radioiodine within the preceding nine months will not be eligible.
  -  Patients who plan to withdraw from thyroid hormone prior to dosimetry.
  -  Patients who are pregnant.

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

Clinical trial: Assess Vitamin D Levels in Those With & Without Thyroid Cancer

Summary: The purpose of this study is to evaluate Vitamin D levels in thyroid cancer patients with active disease compared with thyroid cancer patients in remission and patients with thyroid nodules.

Detailed description: Thyroid cancer is the most common endocrine related malignancy, increasing in incidence in recent years. There are relatively few, well known factors, both genetic and environmental, which predispose to the development of thyroid cancer. Vitamin D deficiency has been associated with other cancers, but the association between vitamin D and thyroid cancer is unknown. We plan to do a case control, pilot study to evaluate the relationship between vitamin D levels and thyroid nodules, thyroid cancer in remission, and active thyroid cancer.

Eligibility: Inclusion Criteria:
  -  Cases: History of Papillary, Follicular, Follicular Variant of Papillary, or Hurthle cell thyroid cancer (both active disease and in remission).
  -  Controls: Individuals with a thyroid nodule, matched to cases for age, BMI, season of vitamin D measurement.
  -  Participating in University of Nebraska Medical Center Thyroid Tumor and Cancer Collaborative Registry database.
  Exclusion Criteria:
  -  Pregnant or breast feeding women
  -  Medullary thyroid cancer
  -  Anaplastic thyroid cancer

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

Clinical trial: Study to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor

Summary: MEK113583 is a Phase II open-label, multi-site study to investigate the objective response rate, safety, and pharmacokinetics of GSK1120212 in subjects with BRAF mutation-positive melanoma who were previously treated with or without a BRAF inhibitor. GSK1120212 is a potent and highly selective inhibitor of MEK activation and kinase activity.


Eligibility: Inclusion Criteria:
  -  Metastatic cutaneous melanoma that was previously treated with: (Cohort A) a BRAF inhibitor either with or without other prior therapy. (Cohort B) at least 1 prior chemotherapy or immunotherapy, without treatment with a BRAF inhibitor.
  -  Documented positive BRAF mutation (V600E, V600K, or V600D).
  -  Subjects must provide archived tumor tissue or undergo fresh tumor biopsy prior to enrollment.
  -  The subject must have a radiographically measurable tumor.
  -  The subject is able to carry out daily life activities without significant difficulty (ECOG performance status score of 0 or 1).
  -  Able to swallow and retain oral medication.
  -  Sexually active subjects must use acceptable methods of contraception during the course of the study.
  -  Adequate organ system function and blood cell counts.
  Exclusion Criteria:
  -  The subject has had major surgery or received certain types of cancer therapy within 21 days before starting the study.
  -  Previous treatment with a MEK inhibitor.
  -  Current use of a prohibited medication listed in the protocol.
  -  Uncontrolled glaucoma.
  -  Brain metastasis, unless previously treated with surgery or stereotactic radiosurgery, and the disease has been stable for at least 2 months prior to enrollment.
  -  Current severe or uncontrolled systemic disease.
  -  History of clinically significant heart, lung, or eye/vision problems.
  -  Significant unresolved side effects from previous anti-cancer therapy.
  -  The subject is pregnant or breastfeeding.

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

Clinical trial: Elastography in Thyroid Nodules

Summary: Nodular goiter is a highly prevalent disease in iodine-deficient areas. Usually nodule assessment includes ultrasonography (US) and fine-needle aspiration (FNA), but some benign nodules can hardly be distinguished from carcinomas. Elastography measures tissue elasticity using sonography, as malignancy is related to stiffness of solid organs. The investigators have designed a study to evaluate the diagnostic accuracy of elastography in nodular goiter. Consecutive patients will be assessed using US, FNA and elastography; the latter will be compared with cytology. Specificity, sensitivity, and predictive values will be calculated.

Detailed description: Aims:
  Primary aim: to evaluate the diagnostic accuracy of elastography in thyroid nodules from a low-risk of thyroid cancer population.
  Secondary aim: to evaluate the usefulness of elastography to detect carcinomas in thyroid nodules with indeterminate FNA.
  Patient selection:
  Inclusion criteria:
  -  Age > 18 yr.
  -  Recruitment in Endocrinology Clinics.
  -  Nodular goiter.
  -  Multinodular goiter with dominant nodule > 1 cm.
  Exclusion criteria:
  -  Toxic nodules
  -  Non-accessible nodules to US or FNA
  -  Cystic nodules
  -  Nodules with calcifications in egg rind
  -  Contraindication for FNA

Eligibility: Inclusion Criteria:
  -  Age > 18 yr.
  -  Recruitment in Endocrinology surgery.
  -  Nodular goiter.
  -  Multinodular goiter with dominant nodule > 1 cm.
  Exclusion Criteria:
  -  Toxic nodules
  -  Non-accessible nodules to US or FNA
  -  Cystic nodules
  -  Nodules with calcifications in egg rind
  -  Contraindication of FNA

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

Clinical trial: Neoadjuvant Treatment of Colon Cancer

Summary: This study will investigate
  -  the effect of preoperative combination chemotherapy in patients with locally advanced colon cancer with mutation in the KRAS, BRAF or PIK3CA gene
  -  the effect of preoperative combination chemotherapy in combination with biological treatment in patients without mutation in the KRAS, BRAF or PIK3CA gene.


Eligibility: Inclusion Criteria:
  -  Histologically verified locally advanced T3 or T4 colon cancer assessed by CT scan
  -  Analysis of KRAS, BRAF, PIK3CA
  -  Age ≥18 år
  -  Performance status ≤ 2
  -  Hematology
  -  ANC ≥ 1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
  -  Biochemistry
  -  Bilirubinaemia ≤ 3 x UNL. ALAT ≤ 5 x UNL
  -  Consent to translational research
  -  Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
  -  Written and orally informed consent.
  Exclusion Criteria:
  -  Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment, active severe infections or other concurrent disease.
  -  Peripheral neuropathy NCI grade >1
  -  Other malignant disease within 5 years prior to enrollment, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ
  -  Other investigational treatment within 30 days prior to treatment start
  -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  -  Bleeding tumors
  -  Hypersensitivity to one or more of the substances

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

Clinical trial: Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, 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 progressive or recurrent, unresectable, or metastatic thyroid cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To determine the efficacy of everolimus in patients with progressive or recurrent, unresectable, or metastatic differentiated thyroid carcinoma.
  Secondary
  -  To determine maximum percentage of tumor reduction in these patients.
  -  To describe activity time to event endpoints.
  -  To assess toxicity.
  -  To determine evolution of serum thyroglobulin.
  -  To perform explorative pharmacogenomic, pharmacokinetic, and translational studies. (exploratory)
  -  To investigate efficacy of everolimus in patients with progressive or recurrent, unresectable or metastatic disease of undifferentiated (anaplastic) or medullary thyroid cancer.
  OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of thyroid cancer meeting ≥ 1 of the following criteria:
  -  Progressive or recurrent disease
  -  Metastatic disease
  -  Unresectable disease
  -  Meeting any of the following thyroid cancer subtypes:
  -  Differentiated thyroid cancer (i.e., papillary, follicular, or Hurthle cell disease) that is radio-iodine refractory
  -  Undifferentiated thyroid cancer (i.e., anaplastic disease)
  -  Medullary thyroid cancer
  -  Must have received prior everolimus or other mTOR inhibitor therapy
  -  Patients with history of brain metastasis who are neurologically stable following definitive radiation and/or surgery and do not require corticosteroids allowed
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance score 70-100%
  -  ANC ≥ 1,500/mm^³
  -  Platelet count ≥ 100,000/mm³
  -  Hemoglobin ≥ 5.6 mmol/L
  -  Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  -  ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for known liver metastases)
  -  Serum creatinine ≤ 2 times ULN
  -  Negative pregnancy test
  -  No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed and with no current evidence of malignancy within the past 2 years
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Biomarkers in Blood Samples From Patients With Refractory Non-Small Cell Lung Cancer Previously Treated With Sorafenib Tosylate

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is studying biomarkers in blood samples from patients with refractory non-small cell lung cancer previously treated with sorafenib tosylate.

Detailed description: OBJECTIVES:
  -  To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell lung cancer treated with sorafenib tosylate on protocol ECOG-2501.
  -  To determine the association between BRAF, KRAS, or EGFR mutation status and clinical benefits in patients treated with this regimen.
  OUTLINE: This is a multicenter study.
  DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of refractory non-small cell lung cancer
  -  Received sorafenib tosylate on protocol ECOG-E2501
  -  Available blood specimens
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: A Study of RO5212054 (PLX3603) in Participants With BRAF V600-Mutated Advanced Solid Tumors

Summary: This open-label, multi-center study will evaluate the safety, tolerability, and pharmacokinetics of RO5212054 [PLX3603] in participants with BRAF V600-mutated advanced solid tumors. Cohorts of participants will receive escalating oral doses of RO5212054. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Advanced solid tumor
  -  Dose-escalation phase: Histologically confirmed, newly diagnosed or relapsed/ refractory unresectable American Joint Committee on Cancer (AJCC) Stage IIIC or IV disease
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  -  Adequate liver, renal and bone marrow function
  Exclusion Criteria:
  -  Participants for whom standard therapy exists and is considered appropriate by the investigator
  -  Prior treatment with an inhibitor of BRAF (sorafenib allowed)
  -  Active Central nervous system (CNS) lesions, or history of or known carcinomatous meningitis
  -  Treatment with any chemotherapy, radiotherapy, immunotherapy or investigational agent within 28 days prior to first dose of study drug
  -  Anticipated or ongoing anti-cancer therapies other than those administered in this study
  -  Serious cardiovascular illness within the 6 months prior to study drug administration

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

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: 40-year-old female with thyroid cancer; genetic feature: BRAF

Clinical trial: A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases

Summary: This open-label study will assess the safety and efficacy of RO5185426 in previously treated metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation (cobas 4800 BRAF V600 Mutation Test)
  -  Brain metastases for which surgical resection is not a treatment option
  -  Patients must have failed at least one previous treatment for brain metastases
  -  Requiring corticosteroids for symptom control
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  Exclusion Criteria:
  -  Increasing corticosteroid dose during the 7 days prior to study entry
  -  Previous malignancy within the past 2 years, except for 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
  -  Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug

Relevance to patient case: not relevant