araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Trial Comparing Oral Pilocarpine (Salagen) Versus Submandibular Salivary Gland Transfer Protocol, For the Prevention of Radiation (XRT) Induced Xerostomia in Head and Neck Cancer Patients

Summary: This is a study to see whether the drug Salagen or salivary gland transfer is better for the prevention of dryness of the mouth in patients with head and neck cancer receiving radiation treatment.


Eligibility: Inclusion Criteria:
  1. Previously untreated and confirmed histological diagnosis of squamous cell/adenoid cystic carcinoma of the oropharynx, hypopharynx, larynx, and patients with unknown primary tumor with metastases to the neck nodes and squamous cell carcinoma of the skin of head and neck region with ipsilateral neck nodes (more than one node) metastases.
  2. Radiation volume to encompass > or equal to 80% of major salivary glands (parotids and the non-transferred submandibular salivary gland) and have > or equal to 50 Gys delivered to that volume via external beam.
  3. Karnofsky performance score > or equal to 70
  4. Minimum age 18 years
  5. The patient must sign a study-specific informed consent prior to study entry
  6. Expected survival > or equal to one year
  Exclusion Criteria:
  1. Carcinoma of nasopharynx, oral cavity, N3 disease, bilateral neck node involvement, pre-epiglottic space involvement, involvement of level 1 nodes on either side of the neck, and patients with post-operative recurrent disease.
  2. Salivary gland malignancy
  3. Salivary gland disease
  4. Use of anti-cholinergic drugs and tricyclic drugs
  5. Delay in XRT of more than 8 weeks following the curative surgery
  6. Pregnant or lactating females are not eligible. Patients of childbearing potential should agree to use an effective method of contraception
  7. Prior head and neck irradiation
  8. Recurrent disease
  9. Allergy to pilocarpine
  10. Patients with uncontrolled asthma, acute iritis, or narrow angle glaucoma

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: An Interactive Program to Improve Care for Children With CF

Summary: The purpose of this study is to evaluate the impact of an internet based program for children and families (CF.DOC) with Cystic Fibrosis on health outcomes. The program provides for virtual visits, a personal health record, messaging with clinicians and several tools for monitoring self-care behaviors. We anticipate that this intervention will provide for more intensive monitoring and feedback of self-care behaviors and will lead to improved health status and in particular nutritional status

Detailed description: Subjects will be drawn from the pool of children who receive their care at the LPCH/Stanford Cystic Fibrosis Center. A letter will be sent to all eligible patients inviting them to participate in the study. This letter will also be available in the CF clinic. All subjects who agree to participate in the study will have the study described to them by a research assistant either in person or over the phone. Informed consent will be obtained all on subjects. Subject who elect to participate will be randomized into either an intervention group or a control group . Subjects in the intervention group will be given Internet Access to the program CF.DOC. They will also be given training in how to use the program for communication with their clinicians, participating in a virtual visit and using online forms and surveys. Subjects in the control group will be advised that they will receive usual care and will have access to CF.DOC at the completion of the study. At the beginning of the study and at 3 month intervals subjects will be asked to complete a cystic fibrosis Quality of life survey. At the beginning and end of the study all subjects will complete a patient experience questionnaire (CAPHS 2.0 CCC supplement ) and an CF.DOC evaluation survey. As part of their regular care all subjects will also have their nutritional status measured and pulmonary function assessed. subjects in the intervention group will asked to define treatment goals that are important to them (e.g. attending camp or participating in sports) and to define health measures that will help monitor progress in meeting these goals e.g. weekly weights or pulmonary function. Subjects in the intervention group will be asked to log onto CF.DOC at least one time per month.

Eligibility: Inclusion Criteria: Patients with Cystic Fibrosis diagnosed by a sweat chloride analysis and/or testing for the CF gene between the ages of 1 month and 21 years of age. Patients must also be English speaking -
  Exclusion Criteria: Non-English speaking patients

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene

Summary: In the core study, participants with unresectable or metastatic gastrointestinal stromal tumors expressing c-kit were treated with either 400 mg or 600 mg imatinib mesylate for 3 years. The 10 year extension study allowed participants, who successfully completed the core study, to continue study treatment with imatinib mesylate provided they still benefited from treatment and did not demonstrate safety concerns as per the investigator's opinion.


Eligibility: Inclusion Criteria:
  -  Men and non-pregnant women ≥18 years of age with the histopathologically documented diagnosis of malignant GIST that was unresectable and/or metastatic. Confirmation of KIT (CD117) expression via immunohistochemical analysis of tumor sample was also required
  -  At least one measurable lesion, as defined by Southwestern Oncology Group (SWOG) Solid Tumor Response Criteria, which had not been previously embolized or irradiated
  -  Performance status ≤3 as defined by the Eastern Cooperative Oncology Group (ECOG) criteria, as well as a life expectancy ≥6 months and adequate end organ function defined as follows: Total bilirubin <1.5 times upper limit of normal (ULN), aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) <2.5 x ULN (or <5 x ULN if hepatic metastases were present), creatinine <1.5 x ULN, absolute neutrophil count (ANC) >1.5 x 10^9/L, platelet count >100 x 10^9/L
  Exclusion Criteria:
  -  Patients with fewer than five years of disease-free survival from any other (non-GIST) malignancy except if the other malignancy was not currently clinically significant and did not require active intervention or if the other malignancy was a basal cell skin cancer or a cervical carcinoma in situ
  -  Patients with known brain metastases
  -  Evidence of any of the following disorders: Grade III/IV cardiac failure as defined by the New York Heart Association Criteria, severe concomitant disease, acute or known chronic liver disease (i.e. chronic active hepatitis, cirrhosis) or HIV infection
  -  Chemotherapy or other investigational therapy within four weeks prior to study entry (six weeks for nitrosourea or mitomycin-C) and/or radiotherapy to ≥25% of the bone marrow
  -  Inability to cooperate
  -  Major surgery within two weeks or exposure to other investigational agents within 28 days of entry into the study
  Other protocol-defined inclusion / exclusion criteria may have applied.

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which type of radiation therapy is more effective in treating prostate cancer.
  PURPOSE: This randomized phase III trial is studying different types of radiation therapy to compare how well they work in treating patients with stage I, stage II, or stage III prostate cancer.

Detailed description: OBJECTIVES:
  -  Compare the efficacy of neutron and photon radiotherapy vs hypofractionated intensity modulated radiation, in terms of a lower frequency of chronic complication rate (chronic toxicity and disease-free survival), in patients with favorable to intermediate prognosis, stage I-III adenocarcinoma of the prostate.
  OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of disease (T1 vs T2 vs T3). Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients undergo neutron radiotherapy over 15-45 minutes 5 days a week for 2 weeks followed by photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks.
  -  Arm II: Patients undergo photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks followed by hypofractionated photon irradiation over 15-45 minutes 5 days a week for 2 weeks.
  After completion of study treatment, patients are followed periodically for 5 years and then yearly thereafter.
  PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed adenocarcinoma of the prostate
  -  Stage I-III disease (T1-T3, N0, M0)
  -  No clinical or radiographic evidence of metastasis
  -  If prostate-specific antigen (PSA) ≥ 10.0 ng/mL and Gleason score is 7, a radioisotope bone scan must show no evidence of metastasis
  -  No evidence of lymphatic or visceral metastases of the abdomen or pelvis on CT scan or MRI
  -  PSA ≤ 20 ng/mL
  -  Gleason score ≤ 7 (if stage T3 , score must be < 7)
  PATIENT CHARACTERISTICS:
  Performance status
  -  Not specified
  Life expectancy
  -  More than 10 years
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
  PRIOR CONCURRENT THERAPY:
  Endocrine therapy
  -  Prior hormonal therapy allowed provided it was initiated no more than 2 months ago, and may include the following:
  -  Luteinizing hormone-releasing hormone agonists (e.g., goserelin, leuprolide)
  -  Anti-androgens (e.g., flutamide, bicalutamide)
  Radiotherapy
  -  No prior pelvic irradiation
  Surgery
  -  No prior radical prostatectomy

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Development of Tuberculosis Diagnostic Kit

Summary: Pulmonary tuberculosis is one of the most important infectious diseases in human with high mortality.
  Early diagnosis followed by antibiotic treatment is the only way for control of the disease. However, most of commercial tuberculosis diagnostic kits are of moderate sensitivity. Oncoprobe Inc. recently developed a tuberculosis diagnostic kit (HR-103) based on detection of antibody against Mycobacterium tuberculosis in serum. The main purpose of this project is to evaluate the sensitivity and specificity of the kit in detection of pulmonary tuberculosis from saliva, urine, pleura and serum samples.Capilia TB assay and another Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based immunochromatographic assay will be tried to detection tuberculous disease.

Detailed description: Sputum samples from 200 patients with chest or respiratory problems will be collected. Presence of M.
  tuberculosis in the samples will be checked by acid-fast stain and bacterial culture and identification methods.
  At the same time, saliva, urine, and serum samples from these 200 patients and 50 healthy volunteers will be collected. The tuberculosis diagnostic kit (HR-103) from Oncoprobe Inc. or capilia TB assay or another Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based immunochromatographic assay will be used to detect tuberculosis disease from these samples. By comparing the results with the stain and identification results of sputum samples from the 200 patients, the sensitivity and specificity of the kit in detection of pulmonary tuberculosis from saliva, urine,pleura and serum samples, as well as from combination of these samples, will be obtained. In addition to pulmonary tuberculosis, M. tuberculosis causes pleural tuberculosis. Diagnosis of pleural tuberculosis involves determination of activities of adenosine deaminase and interferon-gamma in pleural effusion, which is tedious. We also plan to collect pleural effusion samples from 100 patients, and examined by the tuberculosis diagnostic kit (HR-103) from Oncoprobe Inc. By comparing the results with the adenosine deaminase and interferon-gamma activities of the same samples, the sensitivity and specificity of the kit in detection of pleural tuberculosis from pleural effusion samples will be obtained.

Eligibility: Inclusion Criteria: clinical suspicious of tuberculosis
  Exclusion Criteria:
  -  HIV

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma

Summary: This study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors.

Detailed description: Thymic carcinomas are particularly more concerning due to their aggressive metastatic nature and shorter overall survival, in comparison to their lesser-malignant thymoma counterparts. This necessitates the need for systemic therapy. Due to the paucity of thymic carcinoma cases, the ideal regimen for locally advanced or metastatic thymic carcinomas is not defined.To this point, there has not been a study using imatinib in thymic tumors expressing the KIT tyrosine kinase protein or PDGF tyrosine kinase protein. This study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors.

Eligibility: Inclusion Criteria:
  -  Histological or cytological proof of advanced C-KIT positive or PDGFR positive thymic carcinoma. For protocol purposes, advanced disease is defined as disease
  -  Patient must have at least one documented measurable lesion obtained by imaging within 28 days prior to being registered for protocol therapy.
  -  No prior imatinib therapy.
  -  Age > 18 years at the time of consent
  -  ECOG performance status of 0 or 1
  -  ANC ≥ 1500/mm3,Platelet count ≥ 100,000/mm,Total bilirubin < 1.5ULN,3.10 Serum creatinine ≤ 1.7 mg/dl,ALT and AST ≤ 3 x ULN
  Exclusion Criteria:
  -  Clinically significant infections as judged by the treating investigator
  -  Clinically significant concurrent illnesses
  -  Females of childbearing potential not using birth control or breastfeeding
  -  Prior radiation therapy > 25% of the bone marrow
  -  Symptomatic brain metastasis
  -  History of Grade III/IV cardiac problems
  -  History of major surgery within 14 days prior to being registered
  -  Treatment with any investigational agent within 30 days prior to being registered for protocol therapy.

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers.

Summary: It is hypothesized that the NMP22(Nuclear Matrix Protein) Bladder Check ® Test will demonstrate improved sensitivity over that of standard urine cytology for patients with superficial transitional cell carcinoma at high risk of recurrence.

Detailed description: Patients who have been previously treated for bladder cancer and are at a high risk for recurrence are being monitored for recurrence every 3 months with urine cytology and cystoscopy as part of standard care.The NMP22 Bladder Cancer ® Test Kit has been designed to provide an alternative to regular urine cytology. A urine sample will be provided and divided with a portion being used to assess the NMP22 test kit and the remaining sample to be sent to the lab for regular urine cytology. Patient charts will be reviewed by a medical student to record age, clinical stage, pathologic stage, time to disease progression/recurrence, site of recurrence and survival data.

Eligibility: Inclusion Criteria:
  -  · History of pTis, pT1, large (>2cm) pTa or multiple pTa bladder cancer tumours.
  Written Informed Consent prior to any study-related procedures.
  Exclusion Criteria:
  -  History of bladder cancer tumours other than those listed in inclusion

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Study of XL820 Given Orally Daily to Subjects With Solid Tumors

Summary: The purpose of this study is to assess the safety and tolerability of the KIT inhibitor XL820 when given orally daily to adults with advanced solid tumors.


Eligibility: Inclusion Criteria:
  -  Subject has a histologically confirmed solid tumor that is metastatic or unresectable for which known effective measures do not exist or are no longer effective, and there are no known therapies to prolong survival
  -  Subject is at least 18 years old
  -  Subject has ECOG performance status ≤ 2
  -  Subject has a life expectancy of > 3 months
  -  Subject has adequate organ and marrow function
  -  In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level ≥ 20 ug/dL (552 nmol/L) 30-90 minutes after injection of ACTH
  -  Subject has given written informed consent
  -  Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study.
  -  Female subjects of childbearing potential must have a negative pregnancy test at screening.
  Exclusion Criteria:
  -  Subject has received anticancer treatment within 30 days before the first dose of XL820, or has not recovered to grade ≤ 1 from adverse events due to agents administered more than 30 days earlier
  -  Subject has received radiation to ≥ 25% of his/her bone marrow within 30 days of XL820 treatment
  -  Subject has received an investigational agent within 30 days of the first dose of XL820
  -  Subject has known brain metastases
  -  Subject has known uncontrolled intercurrent illness
  -  Subject is pregnant or lactating
  -  Subject is known to be positive for HIV
  -  Subject has a known allergy or hypersensitivity to any of the components of the XL820 formulation

Relevance to patient case: possibly relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer

Summary: Renal cancer is frequent and its diagnosis mainly dependant on imaging. More than 50% of renal tumors are currently diagnosed without symptoms. However, 20% of small solid tumors are benign and this percentage is much higher in atypical cystic tumors Bosniak II and III, where 76% and 59% are benign respectively. Determining the malignancy by imaging in these cases is difficult and sometimes impossible. The fine needle aspiration (FNA) cytology or biopsy is necessary. The diagnostic sensitivity and specificity with biopsy are high, but the potential tumor contamination is a major risk. The FNA cytology is simple and safe, but its sensitivity is about 50%. We are conducting a multicentric prospective study to add the molecular markers in FNA cytology as a new diagnostic method in imaging-indeterminate renal tumors.
  Four molecular markers including MN/CA9, vimentin, KIT, and S100A1 will be studied. These four markers have been reported to have a differential diagnostic value in renal tumors. MN/CA9 and vimentin are often found in conventional renal cancers. KIT is frequently expressed in renal oncocytomas and chromophobe renal cancers. S100A1 may further distinguish renal oncocytoma from chromophobe renal cancer. These markers will be analyzed by real time polymerase chain reaction (RT-PCR).
  The aim of this study is to evaluate the diagnostic performance of the association cytology-molecular markers in imaging-indeterminate renal tumors (small solid tumors and cystic tumors ≥ Bosniak III). About 156 patients will be included in five French clinical centers including Saint-Etienne, Marseille, Grenoble, Toulouse, and Nancy.
  The expected results will improve the preoperative diagnostic accuracy in renal tumors.


Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of kidney tumor < 4 cm
  -  Cystic kidney tumor (Bosniak > IIF)
  -  Consent signed
  Exclusion Criteria:
  -  Benign tumor confirmed
  -  Impossibility to do abdominal pelvic ultra-sound or abdominal thoracic scanner
  -  Contraindication for renal puncture

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Cryoablation kills cancer cells by freezing them. Giving chemotherapy together with cryoablation may kill more cancer cells.
  PURPOSE: This clinical trial is studying how well giving cyclophosphamide together with cryoablation works in treating patients with advanced or metastatic epithelial cancer.

Detailed description: OBJECTIVES:
  -  Document radiologic and/or tumor marker response to cryotherapy of tumor lesions followed by cyclophosphamide.
  OUTLINE: This is a pilot study.
  Patients undergo percutaneous biopsy of the targeted lesion prior to cryoablation. Patients then undergo percutaneous or open cryotherapy of the largest or most accessible lesion on day 0. On day 3, patients receive cyclophosphamide IV over 1 hour.
  Tumor markers (if applicable) are assessed at baseline and monthly during study until marker progression.
  After completion of study therapy, patients are followed periodically for up to 3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of epithelial solid tumors of any of the following sites or types:
  -  Lung (closed to accrual as of 4/2/2009)
  -  Renal
  -  Prostate
  -  Breast (closed to accrual as of 4/2/2009)
  -  Sarcoma (closed to accrual as of 4/2/2009)
  -  Colon (closed to accrual as of 4/2/2009)
  -  Liver(closed to accrual as of 4/2/2009)
  -  Pancreatic (closed to accrual as of 4/2/2009)
  -  Bone (closed to accrual as of 4/2/2009)
  -  Head and neck (closed to accrual as of 4/2/2009)
  -  Melanoma (closed to accrual as of 4/2/2009)
  -  Carcinoma of unknown primary (closed to accrual as of 4/2/2009)
  -  Advanced or metastatic disease
  -  Ineligible for or unwilling to undergo surgical resection
  -  Eligible for cryotherapy but not expected to be cured by cryotherapy alone
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  Life expectancy > 3 months
  -  Creatinine < 2.5 mg/dL
  -  Platelet count >75,000/mm³
  -  INR< 1.5
  -  No known HIV positivity
  -  No active, uncontrolled infection
  -  Not pregnant
  -  Negative pregnancy test
  -  Women of childbearing potential must practice adequate contraception
  -  No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant