araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Blood Sample Analysis in Predicting Overall Survival in Patients With Recurrent or Metastatic Head and Neck Cancer

Summary: RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This research study is looking at blood sample analysis in predicting overall survival in patients with recurrent or metastatic head and neck cancer.

Detailed description: OBJECTIVES:
  -  To validate the mass spectrometry profile that is predictive of survival benefit in patients with recurrent or metastatic head and neck squamous cell carcinoma treated with EGFR inhibitors.
  OUTLINE: Plasma and serum samples are analyzed by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry and classified according to prognosis ("good" vs "poor") using a previously developed predictive algorithm.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of recurrent or metastatic head and neck squamous cell carcinoma
  -  Meets 1 of the following criteria:
  -  Enrolled on clinical trial ECOG-E3301 and previously treated with irinotecan hydrochloride and docetaxel
  -  Enrolled on clinical trial VU-VICC-HN-0501 and previously treated with docetaxel and bortezomib
  -  Plasma and serum samples available for analysis
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Protein Expression in Tumor Tissue Samples From Patients With Cancer of the Oropharynx

Summary: RATIONALE: Studying the proteins expressed in samples of tumor tissue from patients with cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors plan better treatment for patients with cancer of the oropharynx.
  PURPOSE: This laboratory study is looking at protein expression in tumor tissue samples from patients with cancer of the oropharynx.

Detailed description: OBJECTIVES:
  -  To investigate if some of the differences in gene expression are also reflected at the protein level.
  -  To determine whether differences in gene expression that are also reflected at the protein level can be used to develop markers for early detection and disease surveillance.
  -  To identify targets for therapy.
  OUTLINE: Archived tumor tissue samples are analyzed for expression of standard immunohistological markers (e.g., p16, p53, and Ki-67) as well as expression of genes identified in a previous gene expression study. Protein expression data are tested for clinical and demographic correlates and compared with gene expression data.

Eligibility: Inclusion Criteria:
  -  Diagnosis of squamous cell carcinoma of the oropharynx
  -  Tumor tissue samples available from Vanderbilt Head and Neck Tumor Repository and Vanderbilt Pathology archives
  Exclusion Criteria:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Biomarkers in Patients With Head and Neck Cancer and in Healthy Volunteers

Summary: RATIONALE: Studying samples of blood, tissue, and saliva in the laboratory from patients with cancer and from healthy volunteers may help doctors identify and learn more about biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at biomarkers in patients with head and neck cancer and in healthy volunteers.

Detailed description: OBJECTIVES:
  -  Correlate the differences in serum protein profiles with the differences in the number of peptide matches in patients with squamous cell carcinoma of the head and neck and in healthy volunteers.
  -  Correlate protein levels with the largest difference in peptide matches in sera in these participants.
  OUTLINE: This is a prospective study.
  Participants undergo blood, tissue, and saliva collection for biological studies. Samples are analyzed for albumin-bound and non-albumin-bound proteins or IgG via liquid chromatography and tandem mass spectrometry (LC-MS-MS), ELISA, proteomic profiling, and protein expression.
  PROJECTED ACCRUAL: A total of 50 patients and 50 healthy volunteers will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets one of the following criteria:
  -  Diagnosis of squamous cell carcinoma of the head and neck
  -  Healthy volunteer matched by sex, race, birth decade, or smoking status (e.g., current smoker, former smoker, or nonsmoker)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Microsphere-Delivered Cytokines in Increasing Tumor Response in Lymphocytes From Patients With Head and Neck Cancer

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about how interleukin-2, interleukin-12, and GM-CSF delivered in microspheres increase the body's ability to kill tumor cells.
  PURPOSE: This laboratory study is looking at microsphere-delivered cytokines to see if they increase tumor response in lymphocytes from patients with head and neck cancer.

Detailed description: OBJECTIVES:
  -  Determine whether local sustained delivery of cytokines (interleukin-2, interleukin-12, or sargramostim [GM-CSF]) in biodegradable microspheres augments antitumor response in human peripheral blood lymphocytes (PBLs) obtained from patients with squamous cell carcinoma of the head and neck, as evaluated in a human/SCID chimeric mouse model.
  -  Assess the potential of cytokine-loaded microspheres combined with dendritic cells (pulsed with tumor peptide) obtained from these patients to enhance long-term immunity against the tumor, as evaluated in a human/SCID chimeric mouse model.
  -  Evaluate the antitumor effect of the more effective approach (objective I or II) against established tumors in the mouse model.
  OUTLINE: Biopsies of tumor are obtained during surgical resection. Patients undergo phlebotomy or leukapheresis to obtain peripheral blood lymphocytes (PBLs). PBLs, tumor tissue, and cytokine-loaded microspheres are coengrafted into SCID mice. Tumor growth and immune response are determined.
  Dendritic cells are obtained from PBLs, expanded in culture, and pulsed with either autologous tumor cell lysates or peptide eluted from the tumor cells. The dendritic cells are coengrafted with tumor cells, PBLs, and cytokine-loaded microspheres into SCID mice. The mice are then challenged with autologous tumor cells, and antitumor response is determined.
  PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed squamous cell carcinoma of the head and neck
  -  Tumor tissue shows engraftment in severe combined immunodeficient (SCID) mice or growth in tissue culture
  PATIENT CHARACTERISTICS:
  Age
  -  20 to 80
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No known immunocompromised disease or condition
  -  No social, physical, or psychiatric condition that would preclude leukapheresis
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified
  Other
  -  No concurrent immunosuppressive medication

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Postoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk

Summary: The purpose of this study is to determine the treatment outcome of postoperative concurrent chemoradiation for head and neck squamous cell carcinoma with multiple minor risks.

Detailed description: Currently, postoperative chemoradiation is recommended for head and neck squamous cell carcinoma with some poor prognostic feature, such as extracapsular spread of metastatic lymph node, or positive resection margin. Other patients may receive postoperative radiotherapy only, if they have other risk factors. In our previous study, if there are 3 or more "minor" risk factors, the 3-year recurrence rate was 55%. This outcome was far inferior to patients who had minor risk factors less than 3. Thus, we believe that current postoperative radiotherapy is insufficient for patients with multiple minor risks. A clinical trial should be raised to help these patients. However, the patient number of this group is not enough for large scale, phase 3 trial. So we arranged this phase II trial of postoperative chemoradiation to test and prospectively observe the treatment outcome.

Eligibility: Inclusion Criteria:
  -  Primary squamous cell carcinoma of head and neck, after tumor excision and neck dissection, pathology has confirmed three or more of the following adverse prognostic factors, including:
  1. Marginale surgery but a safe distance from the residual tumor ≦ 4mm.
  2. The tumor is located in the hard palate or the retromolar region.
  3. Poorly differentiated cell type.
  4. Tumor invasion to the nerve.
  5. Tumor invasion to lymphatic vessels.
  6. Tumor invasion to the small blood vessels.
  7. Tumor invasion to the bone.
  8. Tumor invasion to the skin.
  9. Depth of tumor invasion ≧ 10mm.
  10. Occurred in single lymph node metastasis.
  Exclusion Criteria:
  -  No or presence of adverse prognostic factor but less than 2.
  -  Presence of either one conditions listed here: positive resection margin, resection margin negative but less than 1 mm, pathologic N2 or N2, or presence of nodal metastasis with extracapsular spreading.
  -  ECOG performance status > 2.
  -  Previous cancer history (except basal cell or squamous cell skin cancer) or other synchronous malignant disease.
  -  Women during pregnancy.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

Summary: The purpose of this study is to determine the feasibility, easy removability, safety, and migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring FCSEMS for benign biliary stricture.

Detailed description: Benign biliary strictures (BBS) are usually managed with plastic stents, whereas placement of uncovered metallic stents has been associated with failure related to mucosal hyperplasia. Fully covered self-expanding metal stent(FCSEMS) placement was reported as a useful method for BBS. However, stent migration was a frequent complication of CSEMS placement. Recently, flared end FCSEMS was developed to decrease stent migration, and anchoring CSEMS was newly developed.

Eligibility: Inclusion Criteria:
  -  Patient over 18 years old
  -  Patient with benign bile duct stricture
  Exclusion Criteria:
  -  No written informed consent
  -  Malignant biliary obstruction
  -  Patients with uncorrectable severe coagulopathy
  -  Patients with severe cardiopulmonary disease precluding sedation

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Customized Headrest or Standard Headrest in Holding Patients Still While Undergoing Radiation Therapy for Head and Neck Cancer

Summary: RATIONALE: Using a customized headrest to hold patients in one position may help doctors plan treatment for patients with head and neck cancer. It is not yet known whether a customized headrest is more effective than a standard headrest in holding patients still during radiation therapy.
  PURPOSE: This randomized clinical trial is studying a customized headrest to see how well it works compared with a standard headrest in holding patients still while undergoing radiation therapy for head and neck cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To evaluate and compare the treatment set-up accuracy of customized vs standard headrest in immobilizing patients undergoing radiotherapy for head and neck cancer.
  -  To determine and compare patient comfort with the two immobilization techniques.
  Secondary
  -  To evaluate radiation therapists' satisfaction with the two immobilization techniques.
  -  To examine and compare the cost effectiveness of the two immobilization techniques.
  OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.
  -  Arm I: Patients are immobilized using the standard thermoplastic four-point fixation mask and the standard headrest system. Patients undergo 3-dimensional conformal radiotherapy as per standard of care.
  -  Arm II: Patients are immobilized using the standard thermoplastic four-point fixation mask and the customized headrest system. Patients undergo 3-dimensional conformal radiotherapy as per standard of care.
  Patients score their comfort using the Visual Analogue Scale during the course of radiotherapy. Radiation therapists complete an evaluation questionnaire for each treatment planning and procedure.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed head and neck malignancy
  -  Planning to undergo radical 3-dimensional conformal radiotherapy (using the Oncentra MasterPlan treatment planning system) at St Luke's Hospital
  PATIENT CHARACTERISTICS:
  -  No evidence of any other significant clinical disorder or laboratory finding that would make it undesirable for the patient to participate in the study
  -  Able to comply with the study, in the opinion of the researcher and/or medical team
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: MRI Mapping in Planning Radiation Therapy to the Base of Skull and Brain in Patients With Nonmetastatic Head and Neck Cancer

Summary: RATIONALE: Diagnostic procedures, such as specialized types of magnetic resonance imaging (MRI), may help in planning radiation therapy that does less damage to normal tissues.
  PURPOSE: This phase I trial is studying using functional MRI to see how well it works in planning radiation therapy in patients undergoing radiation therapy to the base of the skull and/or brain for nonmetastatic head and neck cancer.

Detailed description: OBJECTIVES:
  -  To determine the feasibility of applying established MRI techniques to map functional anatomic regions at potential risk in irradiated normal brain tissue of patients undergoing radiotherapy to the base of the skull and brain for head and neck neoplasms.
  -  To determine changes in cerebral blood flow and blood volume with perfusion MRI techniques in irradiated regions of the brain as a function of the radiation dose.
  OUTLINE: Patients undergo MRI perfusion imaging and functional (fMRI) (standard structural imaging sequences, diffusion tensor imaging, arterial spin labeled perfusion imaging at rest, blood oxygen level dependent, and dynamic susceptibility contrast perfusion weighted MRI) at baseline and 3 and 6 months after completion of radiotherapy. Patients may perform tasks for fMRI studies, including finger tapping, photic stimulation with a flashing light, solving math problems, comparing shapes, giving a speech, or listening to and reciting lists of words during fMRI image acquisition. Patients also undergo daily fractionated intensity-modulated radiotherapy.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed head and neck cancer that requires radiotherapy to the base of the skull
  -  No evidence of metastatic disease
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-1
  -  Life expectancy ≥ 1 year
  -  Not pregnant
  -  Negative pregnancy test
  -  Able to undergo standard CT simulation and radiotherapy treatment planning and delivery, including the capacity to comply with standard immobilization devices to the head and neck for daily irradiation
  -  Able to undergo standard MRI and deemed capable of complying with the immobilization needs and tasks required for functional MRIs
  -  No claustrophobia
  -  No patients with pacemakers, metal fragments in the eye, or certain metallic implants
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Everolimus Versus Placebo in Head and Neck Cancer

Summary: Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy.


Eligibility: Inclusion Criteria:
  -  Diagnosis of Squamous cell carcinoma of the head and neck (stage IVa or IVb). No evidence (absence)of disease by scan.
  -  18 years or older.
  -  Performance status 70% or better.
  -  Adequate marrow, renal and liver function (will be tested by labs). _ Able give consent.
  Exclusion Criteria:
  -  Currently receiving anti-cancer treatment.
  -  Major surgery or traumatic injury within 4 weeks.
  -  Radiotherapy related toxicities.
  -  Lip, nasopharynx, nasal cavity, paranasal sinus, salivary gland, skin, or thyroid primary tumors
  -  Receiving other investigational drugs.
  -  Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent.
  -  Receive immunization with attenuated live vaccines (seasonal flu shot)1 week before starting this .
  -  Show evidence of disease (cancer).
  -  Uncontrolled medical conditions such as: unstable angina, congestive heart failure, diabetes, severely impaired lung function.
  -  Liver disease such as cirrhosis, severe hepatic impairment, Hepatitis B or C.
  -  Active, uncontrolled severe infections
  -  Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
  -  Known History of HIV positivity.
  -  Impaired gastrointestinal function that may alter absorption of Everolimus such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection.
  -  Patients with an active, bleeding diathesis.
  -  Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. )
  -  Male patient whose sexual partner(s) are Women of child bearing potential who are not willing to use adequate.
  contraception, during the study and for 8 weeks after the end of treatment
  -  Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
  -  Patients with a known hypersensitivity to Everolimus or other rapamycin analogues (sirolimus, temsirolimus) or to its excipients.
  -  History of noncompliance to medical regimens.
  -  Patients unwilling to or unable to comply with the protocol.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

Summary: Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase difficulties in determining a proper resection margin. The purpose of this study is to compare the clinicopathological outcomes according to the methods of preoperative biliary drainage in periampullary cancers causing obstructive jaundice, and to find out a proper biliary drainage method.


Eligibility: Inclusion Criteria:
  -  patient who have periampullary tumors causing obstructive jaundice
  -  patient age: ≥20 and ≤85
  -  resectable state of disease
  -  no history of previous chemotherapy or radiotherapy
  -  patients without uncontrollable severe cardiovascular, respiratory disease
  -  Karnofsky performance scale ≥70
  -  informed consent
  Exclusion Criteria:
  -  patients with distant metastasis or locally advanced disease with major vascular invasion
  -  duodenal cancer
  -  biliary drainage before randomization
  -  previous chemotherapy or radiotherapy
  -  uncontrollable active infection except cholangitis
  -  severe comorbid disease (cardiac, pulmonary, cerebrovascular)

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Biomarkers in Tissue and Blood Samples From Patients With Early-Stage Non-Small Cell Lung Cancer

Summary: RATIONALE: Studying samples of blood and tumor tissue 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 tissue and blood samples from patients with early-stage non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Evaluate aberrant methylation patterns in tissue and serum samples from patients with early-stage non-small cell lung cancer (NSCLC) to validate the Johns Hopkins single institutional study.
  -  Attempt to define subgroups of patients at greater risk for recurrent or metastatic disease who may benefit from more aggressive adjuvant therapeutic regimens.
  -  Develop prognostic indicators for disease-specific and overall survival.
  -  Define new potential molecular targets for therapy.
  OUTLINE: Archived tumor and intrathoracic lymph node tissue samples are analyzed for aberrant DNA methylation (p16/CDKN2A, DAP kinase, H-cadherin, APC, and RASSF1A) by methylation-specific PCR. Analyses are then compared with the preliminary data from the Johns Hopkins institutional study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of early-stage non-small cell lung cancer
  -  T1 or T2, N0 disease
  -  Had a lobectomy or greater resection with negative surgical margins (R0 resection)
  -  Available tumor and lymph node specimens from patients enrolled on ACOSOG-Z0040 and ACOSOG-Z0030 trials
  -  Node-negative with recurrent disease within 3 years (cases)
  -  Node-negative patients without recurrent disease (controls)
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant