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

Clinical trial: Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer

Summary: The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma.


Eligibility: Inclusion Criteria:
  -  Locally advanced or hereditary medullary thyroid cancer
  -  Signed informed consent
  -  One or more measurable lesions
  Exclusion Criteria:
  -  Brain metastases or spinal cord compression
  -  Specific laboratory ranges
  -  Specific heart problems
  -  Prior chemotherapy and/or radiation therapy
  -  Participation in other trials within 30 days

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

Clinical trial: Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension

Summary: Mother with severe Iodine deficiency are more likely to have neonates with further poor mental development . In order to select population which could benefit from iodine supplementation, ioduria has been tested but cannot be routinely practised. Strong background data suggest that iodine status could be antenatally correlated with foetal thyroid volume. The aim of that study is to examine correlation between these two parameter in a population of 130 healthy pregnant women.

Detailed description: Iodine is an essential element in thyroid homeostasis, particularly in pregnant woman and her fetus. Various studies have clearly shown that antenatal thyroid disorders at both the mother and the fetus could cause in extreme situations of neurological consequences.
  At a broader scale, subtle alterations of thyroid hormone balance has been implicated in developmental delays and deviations of the IQ bell curve in newborn infants of mothers with elevated TSH.
  The clinical implications of these basic data and public health are yet to confirm.
  It has been clearly established that there is a moderate iodine deficiency in France with a decreasing gradient from west to east. In the Ile de France, there is a moderate iodine deficiency, this has led some teams to propose a systematic supplementation of all women in iodine.
  One way to target women who really need supplements systematic determination of urinary iodine tongue; this assay is reliable but is difficult to implement in an ad hoc practice at the individual level.
  Our team has expertise in the field of fetal thyroid, particularly in its sonographic and reference curves of the perimeter and diameter of the thyroid are now clearly established reliably.
  Knowing that iodine deficiency is causing a decline in maternal urine iodine with a phenomenon goitrigénèse and biological hypothyroidism and that some studies have shown that neonatal thyroid volumes were higher in iodine deficient mothers . We postulate that the measurement of fetal thyroid by our criteria can be correlated with maternal urinary iodine.
  If this were the case, we will have a simple test to identify iodine supplementation in pregnant women.

Eligibility: Inclusion Criteria:
  -  normal single pregnancy in a healthy volunteer
  Exclusion Criteria:
  -  any associated disease
  -  pertubation of thyroid status at 12 GA

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

Clinical trial: Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer

Summary: Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.


Eligibility: Inclusion Criteria:
  -  Recent primary surgery for breast cancer
  -  Early stage breast cancer
  -  Postmenopausal
  -  Hormone receptor positive
  -  Positive lymph node involvement
  Exclusion Criteria:
  -  Metastatic disease
  -  Presence of contralateral breast cancer including DCIS
  -  Progression
  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: Review of Multimodality Management of Anaplastic Thyroid Cancer

Summary: To describe the outcome of patients with anaplastic thyroid cancer treated with hyperfractionated radiotherapy and concomitant chemotherapy


Eligibility: Inclusion Criteria:
  -  anaplastic thyroid cancer treated with multimodality treatment
  Exclusion Criteria:
  -  differentiated thyroid cancer

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

Clinical trial: Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules

Summary: RATIONALE: Finding genetic markers for thyroid cancer in a biopsy specimen may help doctors diagnose thyroid cancer.
  PURPOSE: This clinical trial is studying how well genetic analysis works in diagnosing thyroid cancer in patients with thyroid nodules.

Detailed description: OBJECTIVES:
  -  Evaluate the diagnostic accuracy of biomarkers and mRNA expression analysis using fine-needle aspiration (FNA) biopsy samples from patients with thyroid nodules.
  -  Correlate the level of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples.
  OUTLINE: Patients undergo fine-needle aspiration (FNA) biopsy as part of routine care. Additional thyroid tissue is collected during the biopsy for gene expression analysis. Patients who have already had a biopsy undergo FNA biopsy during thyroidectomy.
  Tissue samples will be examined for gene expression by reverse transcriptase-polymerase chain reaction (PCR), real-time quantitative PCR, and immunohistochemistry.
  PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of a thyroid nodule that requires fine-needle aspiration biopsy or thyroidectomy to exclude a diagnosis of thyroid cancer
  PATIENT CHARACTERISTICS:
  -  Platelet count ≥ 70,000/mm^3
  -  PT (INR) ≤ 14.5
  -  PTT ≤ 35.2
  -  Not pregnant
  PRIOR CONCURRENT THERAPY:
  -  No aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) 7 days before sample procurement

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

Clinical trial: Comparison of I-124 PET/CT, F-18 FDG PET/CT & I-123 Whole Body Scintigraphy for Recurrent Thyroid CA

Summary: The management of thyroid cancer patients with suspicion of recurrent disease based on rising/detectable levels of thyroglobulin (Tg) involves imaging with iodine-123 whole body scintigraphy (I-123 WBS) and F-18 FDG PET/CT. However, the disease is not always detected. The use of another iodine isotope (I-124) with positron emitting characteristics for PET/CT may allow better identification of recurrent disease, thus allowing for more patients to be treated with I-131 as a curative attempt.

Detailed description: The management of thyroid cancer patients with suspicion of recurrent disease based on rising/detectable levels of thyroglobulin (Tg) involves imaging with iodine-123 whole body scintigraphy (I-123 WBS) and F-18 FDG PET/CT. However, the disease is not always detected. The use of another iodine isotope (I-124) with positron emitting characteristics for PET/CT may allow better identification of recurrent disease, thus allowing for more patients to be treated with I-131 as a curative attempt.
  Conducting this study we hope to find whether I-124 PET/CT allows for detection of more lesions in patients with suspected recurrent thyroid cancer than the current standard of care represented by I-123 WBS and F-18 FDG PET/CT.

Eligibility: Inclusion Criteria:- Patient at Nuclear Medicine clinic at Stanford University Medical Center
  -  Treated thyroid cancer.
  -  Detectable levels of Tg.
  -  Referred for I-123 WBS and F-18 FDG PET/CT for detection of recurrent thyroid cancer.
  -  Able to have a I-124 PET/CT the day after I-123 WBS and F-18 FDG PET/CT
  -  Patients older than 18-year-old.
  -  Patients with history of treated thyroid cancer and suspected recurrent thyroid cancer based on detectable levels of Tg.
  -  Patients must have I-123 WBS and F-18 FDG PET/CT performed prior to the I-124 PET/CT.
  -  Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them.
  Exclusion Criteria:- Patients who are not eligible for I-123 WBS and F-18 FDG PET/CT.
  -  Patients who cannot complete I-123 WBS and F-18 FDG PET/CT.
  -  Pregnant women.
  -  Healthy volunteers.
  -  Patients participating in other research studies.

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

Clinical trial: Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer

Summary: The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer that is resistant to radioactive iodine

Detailed description: Additional study details: assess safety and efficacy

Eligibility: Inclusion Criteria:
  -  Radioiodine-refractory metastatic or unresectable locally-advanced thyroid cancer
  -  At least 1 measurable target lesion, as defined by RECIST
  Exclusion Criteria:
  -  Thyroid lymphoma
  -  Previous treatment with anti-angiogenesis agents
  -  No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism within 12 months prior.

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

Clinical trial: Safety Study of PLX4032 in Patients With Solid Tumors

Summary: The primary objective of this FIH study is to assess the safety and pharmacokinetics of PLX4032 in patients with solid tumors. The secondary objective is to assess the pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant melanoma who have the V600E BRAF oncogenic mutation.

Detailed description: Activating mutations of the BRAF gene have been observed in a variety of cancers, including 55-68% of malignant melanomas. In general, oncogenic mutations of BRAF correlate with a poor outcome. PLX4032 is a compound that selectively inhibits oncogenic B-Raf kinase.
  Two extension cohorts of patients with confirmed V600E mutations will be recruited, consisting of advanced melanoma and metastatic colorectal carcinoma.

Eligibility: Inclusion Criteria:
  -  Solid tumors confirmed histologically whose tumors are refractory to standard therapy, or for whom standard or curative therapy does not exist
  -  Patients from whom paired melanoma biopsies are planned must have a V600E+ BRAF mutation confirmed prior to the administration of PLX4032
  -  Previous chemotherapy, immunotherapy, or radiation therapy must have been completed at least 2 weeks prior to starting PLX4032 therapy, and all associated toxicity must be resolved prior to administration of PLX4032
  -  Patients in the Extension cohorts (melanoma or adenocarcinoma of the colon or rectum) must have both a V600E+ BRAF mutation and measurable disease (by RECIST V 1.0 criteria) prior to the administration of PLX4032. All patients enrolled must provide archival or fresh melanoma tumor biopsy for confirmation of V600E+ BRAF mutation status by TaqMan assay
  -  ECOG performance status 0 or 1
  -  Life expectancy ≥ 3 months
  -  Adequate hematologic, hepatic, and renal function
  Exclusion Criteria:
  -  Brain metastases that are progressing or have been documented to be stable for less than 3 months, or for which systemic corticosteroids are required
  -  Investigational drug use within 28 days of the first dose of PLX4032
  -  Uncontrolled intercurrent illness
  -  Refractory nausea and vomiting, malabsorption, or significant bowel resection that would preclude adequate absorption

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

Clinical trial: Iodine I 131 in Treating Patients With Thyroid Cancer

Summary: RATIONALE: Radioactive iodine kills thyroid cancer cells by giving off radiation.
  PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I 131 works in treating patients with thyroid cancer.

Detailed description: OBJECTIVES:
  -  Determine the relationship between estimated absorbed dose of iodine I 131 and tumor response or normal organ toxicity for different dosimetric measures, using data derived from clinical radionuclide therapy studies in patients with thyroid cancer.
  OUTLINE: Patients receive oral dosimetric iodine I 131 (^131I) on day 2 and then undergo nuclear medicine imaging at 0.5-4 hours, 24, 48, and 72 hours after dosimetric ^131I. Single-photon emission computed tomography (SPECT)/CT scans are performed at 0.5-4 hours and 24 or 48 hours over the head and neck region, including the salivary glands. Subsequent SPECT/CT scans are performed over the candidate tumor sites. Patients undergo ^131I therapy on day 11.
  Saliva is collected on days 1 and 2, weeks 2 and 4, and months 3 and 6 to measure saliva flow rate. Blood is collected at baseline and periodically during study to measure FLT3 ligand levels.
  PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of thyroid cancer
  -  Measurable disease by CT scan or nuclear medicine imaging
  -  Eligible, by standard of care criteria, for iodine I 131 therapy
  PATIENT CHARACTERISTICS:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective non-barrier method contraception (e.g., combined or progesterone-only oral contraceptive pill, intrauterine device, depot progesterone, or stable relationship with a partner who has had a vasectomy)
  -  No other malignancy within the past 5 years except squamous cell or basal cell carcinoma of the skin
  -  No nonthyroidal conditions known to affect iodine I 131 uptake (e.g., New York Heart Association class III or IV congestive heart failure or renal failure)
  -  No alcoholism or drug abuse within the past 2 years
  -  No severe emotional, behavioral, or psychiatric problems that would preclude study compliance (e.g., severe claustrophobia)
  PRIOR CONCURRENT THERAPY:
  -  No intravenous water-soluble radiographic contrast within the past 4 weeks
  -  No iodinated contrast agent within the past 3 months
  -  No concurrent drugs that may affect thyroid or renal function (e.g., renal drugs, lithium, amiodarone, other iodine-containing medication, or corticosteroids)
  -  No other concurrent investigational drugs

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

Clinical trial: Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients

Summary: In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of 90-95% of patients. This favorable prognosis is the result of an effective primary therapy, which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7GBq (100mCi) in case of significant risk of persistent disease. Few centers investigated the possibility to administer lower doses of 131I (1GBq, 30 mCi), in order to limit the potential long-term adverse complications for patients and to respond to radioprotection rules for family members and medical staff.
  Radio-iodine ablation requires TSH stimulation, which was historically achieved by thyroid hormone withdrawal for 3 to 5 weeks. During this period, patients suffered from symptoms of hypothyroidism. The recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge, USA) was approved in Europe in 2005 as an alternative stimulation procedure to withdrawal during ablation. It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn). However, this a costly drug (800 € per patient), whose economic efficiency needs to be checked.

Detailed description: This is a multicentric, randomized, controlled, open-label phase III clinical trial involving 26 French centers. It aims at comparing four strategies of management of postoperative radioiodine ablation, each strategy combining a method of TSH stimulation (thyroid hormone withdrawal or rhTSH (Thyrogen®, Genzyme)) and an activity of 131I (low-dose (1GBq, 30 mCi) or high-dose (3,7GBq, 100 mCi)).

Eligibility: Inclusion Criteria:
  -  18 year or older
  -  Newly diagnosed differentiated papillary or follicular thyroid carcinoma who underwent total thyroidectomy between 30 and 60 days before randomization and treated by LT4 for at least one month.
  -  Patients are all staged pT1<1cm N1 or pT1>1cm N0 N1 Nx or pT2 N0
  -  The performance status is 0 or 1.
  -  All patients will provide written consent to participate.
  Exclusion Criteria :
  -  partial thyroidectomy
  -  patients treated by LT4 less than one month
  -  time from thyroidectomy superior to 60 days at randomization
  -  patients with Hurtle cancer or aggressive histology
  -  Patients staged pT1<1cm N0 or T2 N1 or T3 or T4 or M1
  -  patients for which the use of rhTSH is required for medical reasons
  -  patients with major concurrent medical disorder (cardiac, renal, liver, respiratory)
  -  patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission for at least 2 years)
  -  patients with recent history of drugs affecting thyroid function, including iodine containing medications or radiocontrast agents
  -  patients with recent history of 131I whole body scan
  -  pregant women or breast-feeding

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

Clinical trial: Prognostic Significance of Fine-Needle Aspiration Cytology Features in Papillary Thyroid Carcinoma

Summary: The purpose of this study is to investigate the relationship between prognosis and fine needle aspiration cytology character of papillary thyroid cancer.

Detailed description: Papillary thyroid carcinoma is the most common thyroid malignancy worldwide. The influence of clinicopathologic features on prognosis has been examined, but the relationship between cytologic features obtained by fine-needle aspiration (FNA) and prognosis has been minimally studied. We retrospectively studied the cytologic features with computerized morphometry in 83 patients with usual-type papillary thyroid cancer and followed them for more than 10 years except for one with metastasis at diagnosis. The cytologic features of FNA and recurrence of cancer were examined statistically.

Eligibility: Inclusion Criteria:
  -  Papillary thyroid cancer diagnosed in NTUH from 1977 to 2000
  Exclusion Criteria:
  -  Patient without complete medical record

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

Clinical trial: Expression of NIS Protein and mRNA in Thyroid Tumors

Summary: The uptake of iodide by thyroid cells requires the expression of sodium iodide symporter (NIS). Thyroid benign and malignant tumors have low iodide uptake activity. Previous studies of NIS expression with RT-PCR and immunohistochemistry showed divergent data. NIS protein was overexpressed in thyroid cancer. The aim of this study was to investigate the NIS transcript levels and its presence and localization in 30 samples of thyroid tumors (14 benign and 16 malignant) and in their surrounding non-tumoral tissues (NT), by real time RT-PCR and immunohistochemistry, respectively. Our results revealed lower gene expression in 78.6% of the benign tumors and 100% of the carcinomas when compared with the NT samples, using GHPDH as a housekeeping gene. Immunohistochemical staining revealed presence of NIS protein in 100% of the non-tumoral samples, 100% of the benign tumors and 93.75% of the malignant tumors. NIS protein was identified at basolateral membrane in 23.3% of non-tumoral samples, 14.3% of benign and 12.5% of malignant tumors. Stronger cytoplasmatic immunostaining of NIS protein was detected in 64.3% of benign tumors and in 87.5% of malignant tumors when compared to NT. Association between low gene expression and strong cytoplasmatic immunostaining was found in 50% of benign tumors and 87.5% of malignant tumors. We concluded that the reduced NIS gene expression in thyroid tumors associated with strong intracytoplasmatic staining may be due to its incapacity to migrate to cellular membrane.

Detailed description: The aim of this study was to quantify NIS transcript levels by real time PCR and to determine the presence and cellular localization of NIS protein by immunohistochemistry, in benign and malignant thyroid tumor cells and to compare with their paired surrounding non-tumoral cell. NIS expression was also compared to that of the TSHR

Eligibility: Inclusion Criteria:
  -  PAtients with thyroid tumors undergoing surgery for total or partial thyroidectomy
  Exclusion Criteria:
  -  Pregnancy

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

Clinical trial: Pyrosequencing of the BRAFV600E Mutation

Summary: To investigate the diagnostic efficiency of pyrosequencing for the mutant BRAF allele in ultrasound (US)-guided fine needle aspiration biopsies (FNAB) of thyroid incidentalomas.


Eligibility: Inclusion Criteria:
  -  Patients with thyroid nodule larger than 1 cm, or nodule smaller than 1 cm that required further evaluation because of suspicious ultrasound findings
  Exclusion Criteria:
  -  Patients who refuse participation.

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

Clinical trial: Prediction of Thyroid Cancer From Ultrasonographic Characteristics of Thyroid Nodules

Summary: The aim of this study is to identify which ultrasonographic feature or a combination of features is the best predictor of thyroid cancer in thyroid nodules.


Eligibility: Inclusion Criteria:
  -  Subjects with thyroid nodules over 10 mm in the longest diameter
  -  Euthyroid or hypothyroid subjects with a solitary thyroid nodule or multinodular goiter
  -  Subjects with a hypoactive nodule in the thyroid scan and a low TSH
  Exclusion Criteria:
  -  Subjects with four or more thyroid nodules that are over 10 mm
  -  Subjects with low TSH and hyperactive nodule on thyroid scan

Relevance to patient case: not relevant