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

Clinical trial: Developing a Checklist of Lymphedema Symptoms in Patients With Head and Neck Cancer

Summary: RATIONALE: Developing a symptom checklist for late-effect lymphedema may help doctors learn more about lymphedema in patients with head and neck cancer and plan the best treatment.
  PURPOSE: This phase I/II trial is developing a checklist of lymphedema symptoms in patients with head and neck cancer.

Detailed description: OBJECTIVES:
  -  To develop and validate a symptom checklist for late-effect lymphedema in patients with head and neck cancer. (Phase I)
  -  To examine late-effect lymphedema symptoms in these patients using the preliminary patient-symptom checklist developed in phase I. (Phase II)
  -  To examine the psychometric properties of the patient symptom checklist. (Phase II)
  OUTLINE:
  -  Phase I: Experts review an initial symptom checklist for late-effect lymphedema symptoms and provide suggestions concerning its revision. The checklist is further revised using the card sorting method. Patients sort cards labeled with symptoms into groups that they feel are appropriate based upon their own symptom experiences. Sorting is performed according to frequency and severity of symptoms. Patients may write down any symptoms which are not listed on the cards.
  Patients undergo collection of demographic and lymphedema-related symptom information. Additional medical information is obtained from patients' medical records.
  -  Phase II: A final symptom checklist for late-effect lymphedema symptoms is constructed based on the preliminary checklist developed in phase I. The psychometric properties of the preliminary checklist are also assessed.
  Patients undergo collection of demographic, lymphedema-related symptoms, and medical information as in phase I.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Patients meeting the following criteria:
  -  Diagnosis of local squamous cell carcinoma of head and neck
  -  Developed lymphedema after cancer treatment
  -  No current evidence of cancer recurrence
  -  No metastatic disease
  -  Identified from oncology practices at the Vanderbilt-Ingram Cancer Center
  -  Volunteer expert meeting the following criteria:
  -  Member of the Pain and Symptom Management Team at Vanderbilt-Ingram Cancer Center OR faculty member/clinician associated with the Principal Investigator's prior clinical research at Vanderbilt Medical Center
  -  Knowledgeable about the symptoms head and neck cancer patients experience
  PATIENT CHARACTERISTICS:
  -  No history of psychotic illness
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  More than 3 months since prior cancer treatment
  -  No concurrent chemotherapy or radiotherapy
  -  No concurrent anti-psychotic 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: Blood Proteins in Predicting Treatment Benefit in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer

Summary: RATIONALE: Studying samples of blood in the laboratory may help doctors learn more about cancer. It may also help doctors predict how well patients will respond to treatment.
  PURPOSE: This research study is looking at proteins in blood samples to predict treatment benefit in patients with recurrent and/or metastatic squamous cell head and neck cancer.

Detailed description: OBJECTIVES:
  -  To identify head and neck squamous cell cancer patients who will benefit from treatment with the EGFR inhibitors (i.e., erlotinib hydrochloride, gefitinib, and cetuximab) and VEGF inhibitor (i.e., bevacizumab), based on predictive proteomic profiles in patient blood samples.
  OUTLINE: This is a multicenter study.
  Blood samples are analyzed for proteomic profile to determine good and bad prognoses in patients treated with or without EGFR inhibitors and/or a VEGF inhibitor.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of squamous cell head and neck cancer
  -  Recurrent and/or metastatic disease
  -  Meets 1 of the following criteria:
  -  Previously treated with EGFR inhibitors and/or VEGF inhibitor on 1 of the following clinical trials, and has available blood samples:
  -  A Phase I/II Study of Bevacizumab (rhu MAb VEGF) in Combination With OSI-774 for Patients With Recurrent or Metastatic Cancer of the Head and Neck
  -  A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck
  -  Previously treated with cetuximab and has blood samples available from protocol VU-VICC-HN-0356
  -  Previously treated with conventional chemotherapy and has blood samples available from protocol VU-VICC-HN-0356
  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: Immunoreactivity to Cetuximab in Cancer Patients

Summary: RATIONALE: Studying samples of blood in the laboratory may help doctors predict which patients will develop hypersensitivity to cetuximab.
  PURPOSE: This research study is looking at hypersensitivity to cetuximab in patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab.

Detailed description: OBJECTIVES:
  -  To examine serum samples from patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab for the presence of antibodies against cetuximab.
  OUTLINE: Serum samples are examined by immunoreactivity screening of IgE, IgG, IgA, and IgM antibodies and complement reaction.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of one of the following:
  -  Head and neck cancer
  -  Advanced colorectal cancer
  -  Previously treated with cetuximab
  -  Serum samples available from patients enrolled in one of the following clinical trials:
  -  VU-VICC-GI-0410 (colorectal cancer)
  -  VU-VICC-GI-0622 (colorectal cancer)
  -  VU-VICC-HN-0356 (head and neck cancer)
  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: Study of Proteins in Head and Neck Cancer Cells

Summary: RATIONALE: Studying proteins in head and neck cancer cells in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at proteins in head and neck cancer cells.

Detailed description: OBJECTIVES:
  -  Define the function and mechanism of LZAP in regulating ARF.
  -  Determine the mechanism and biological consequences of LZAP inhibition of NF-κB.
  -  Determine if LZAP has tumor suppressor activity by conditional targeting of LZAP in mice.
  OUTLINE: Using molecular laboratory techniques, this study examines the biochemical mechanisms by which LZAP activates transcriptional, tumor suppressive activity (both p53-dependent and p53-independent) of ARF and inhibits transcriptional, tumorigenic activity of NF-kB. LZAP regulation of newly identified ARF activities, such as S-phase delay and ARF-mediated B23 degradation are also evaluated. LZAP's tumor suppressive activity is assessed in vivo using a conditional knockout vector to target LZAP in mice and to observe for spontaneous and induced tumor formation. Laboratory analyses used to determine study endpoints include standard recombinant DNA, recombinant protein expression and purification, cell culture and transfection, cell labeling, reporter assays, flow cytometry, yeast-two hybrid, immunoprecipitation, immunoblotting, immunofluorescence, TUNEL assay, ELISA assay, Southern blotting, and protein and gene expression.

Eligibility: DISEASE CHARACTERISTICS:
  -  Head and neck cancer tumor cell line
  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: Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy

Summary: RATIONALE: Studying samples of 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. It may also help the study of cancer in the future.
  PURPOSE: This laboratory study is looking at tumor tissue samples from patients with melanoma who have undergone sentinel lymph node biopsy.

Detailed description: OBJECTIVES:
  -  Develop a predictive model for sentinel lymph node biopsy positivity in patients with melanoma who have undergone sentinel lymph node biopsy.
  -  Develop a survival model for relapse based on sentinel lymph node biopsy positivity.
  -  Assess the genetic determinants in primary melanomas that predict a metastatic phenotype and thereby improve understanding of the biology of the metastases in melanoma.
  OUTLINE: This is a retrospective, case-controlled, multicenter study. Patients are stratified according to Breslow thickness of the tumor (0.75-1.50 mm vs 1.51- 4 mm vs > 4 mm) and gender.
  Archived tumor tissue is analyzed by immunohistochemistry (IHC) for AP2, vascular endothelial growth factor, MMP 2, MCM4, and others, if feasible. Sentinel node biopsies are analyzed by IHC for CD31, LYVE-1, and D2-40 expression. RNA and DNA are also extracted for genetic expression studies and mutation analysis (e.g., BRAF, NRAS, PTEN, CDKN2A).
  Patient data related to relapse and recurrence is collected, if available.
  Peer reviewed and funded or endorsed by Cancer Research UK
  PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Confirmed diagnosis of cutaneous melanoma
  -  Breslow thickness > 0.75 mm
  -  Has undergone sentinel lymph node biopsy
  -  No primary melanoma that has not originated in the skin
  -  No multiple primary melanomas
  -  Currently under clinical followup OR discharged from follow up within the past 3 months
  PATIENT CHARACTERISTICS:
  -  No other malignancy except for nonmelanoma skin cancer or cervical carcinoma in situ
  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: Growth Factor Levels in the Blood of Patients Undergoing Radiation Therapy for Epithelial Cancer

Summary: RATIONALE: Measuring levels of transforming growth factor-beta (TGF-beta) in the blood of patients with epithelial cancers (head and neck, lung, breast, colorectal, and prostate) may help doctors predict how patients will respond to treatment with radiation therapy.
  PURPOSE: This research study is measuring levels of TGF-beta in patients with epithelial cancers who are undergoing radiation therapy.

Detailed description: OBJECTIVES:
  -  To determine whether there is a dose-dependent increase in TGF-beta following radiotherapy in patients with epithelial cancers.
  OUTLINE: Patients undergo blood sample collection prior to treatment, 24-72 hours after the first fraction of radiotherapy, and at the end of radiotherapy. Patients will also be asked for a weekly blood sample, but this is optional. Samples are analyzed to compare pre- and post-treatment TGF-beta levels.

Eligibility: DISEASE CHARACTERISTICS:
  -  Known diagnosis of an epithelial cancer, including any of the following:
  -  Head and neck
  -  Lung
  -  Breast
  -  Colorectal
  -  Prostate
  -  Radiotherapy must be a component of planned treatment therapy
  PATIENT CHARACTERISTICS:
  -  No serious medical or psychiatric illnesses which would prevent informed consent

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

Clinical trial: Study of Tumor Samples From Patients With Ewing Sarcoma

Summary: This laboratory study is looking at tumor samples from patients with Ewing sarcoma. Studying samples of 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

Detailed description: Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Prospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Samples collected from AEWS0031 and patients registered on AEWS08B1 Sampling Method: Non-Probability Sample
  PRIMARY OBJECTIVES:
  I. Determine if mutation of p53, and/or deletion of the p16 locus, have prognostic value in patients with Ewing sarcoma.
  SECONDARY OBJECTIVES:
  I. Estimate the incidence of p53 mutation in Ewing sarcoma samples collected from COG studies.
  II. Estimate the incidence of p16 deletions in Ewing sarcoma samples collected from COG studies.
  III. Prepare and archive amplified genomic DNA from Ewing sarcoma samples collected from COG studies for future biologic analysis.
  OUTLINE: This is a multicenter study.
  Previously archived tumor samples are analyzed for p53 mutations and p16 deletion by immunohistochemistry, FISH, PCR, and DNA sequencing.

Eligibility: Inclusion Criteria:
  -  Diagnosis of Ewing sarcoma
  -  Banked specimens from patients enrolled on AEWS0031

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

Clinical trial: Collecting and Storing Tissue Samples From Patients With Head and Neck Cancer

Summary: RATIONALE: Collecting and storing samples of tissue, blood, and saliva from patients with cancer to study in the laboratory may help the study of cancer in the future.
  PURPOSE: This laboratory study is collecting and storing tissue samples from patients with head and neck cancer.

Detailed description: OBJECTIVES:
  -  Establish a tissue/specimen bank of biologic specimens collected from patients with proven or suspected head and neck cancer.
  -  Establish a database to link materials acquisition and pathologic and clinical information on these patients.
  -  Correlate clinical-pathological findings on these patients with future scientific studies using the patient database.
  -  Test new hypotheses as they emerge.
  OUTLINE: This is a prospective, multicenter study.
  Patients enrolled on active Radiation Therapy Oncology Group clinical trials undergo biopsy or surgical resection of head and neck tumors or premalignant lesions at participating institutions. Tissue and other specimens collected at the time of biopsy or surgery are submitted to the Head and Neck Cancer Tissue/Specimen Bank which acts as a central repository for processing, storing, and preserving patient specimens for translational research. Tissue samples include paraffin-embedded blocks or fresh or frozen samples of normal squamous mucosa, tumors, or premalignant lesions of the upper aerodigestive tract. Other specimens for tissue banking include serum, plasma, and lymphocytes isolated from peripheral blood, as well as samples of patient saliva. Cells obtained from tissue bank specimens may also be used to establish cell lines for future research.
  PROJECTED ACCRUAL: An unlimited number of specimens will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Confirmed or suspected head and neck cancer
  -  Primary site recurrence allowed
  -  Potentially eligible for or participating in an active Radiation Therapy Oncology Group treatment clinical trial
  PATIENT CHARACTERISTICS:
  -  Zubrod performance status 0-1
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  Concurrent radiotherapy, drug therapy, biopsy, or surgery allowed

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 Predicting Response to Treatment in Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer Treated With Carboplatin, Paclitaxel, and Radiation Therapy

Summary: RATIONALE: Studying samples of 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. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This research study is looking at biomarkers in predicting response to treatment in patients with newly diagnosed stage III or stage IV head and neck cancer treated with carboplatin, paclitaxel, and radiation therapy.

Detailed description: OBJECTIVES:
  -  Determine if gene expression patterns that correlate with treatment response and survival can be identified using DNA microarrays in patients with newly diagnosed head and neck squamous cell carcinoma (HNSCC) treated with carboplatin, paclitaxel, and radiotherapy.
  -  Determine if protein expression patterns that correlate with treatment response and survival in HNSCC can be identified using matrix-assisted laser desorption ionization-time-of-flight mass spectrometry (MALDI-TOFMS).
  -  Determine if the molecular signature of human papilloma virus-16 infection can be determined using DNA microarray and MALDI-TOFMS and correlate with gene and protein expression, treatment response, and survival.
  OUTLINE: Tumor tissue samples are analyzed by DNA microarray analysis and validated by quantitative reverse transcription-polymerase chain reaction (PCR). Protein and gene expression patterns are analyzed by laser desorption ionization-time-of-flight mass spectrometry, high performance liquid chromatography, liquid chromatography-tandem mass spectrometry, and PCR. Samples are also analyzed by tissue microarray and immunohistochemistry.

Eligibility: DISEASE CHARACTERISTICS:
  -  Newly diagnosed head and neck squamous cell carcinoma
  -  Stage III-IV disease
  -  Scheduled for pan-endoscopy
  -  Tumor tissue available from patients treated with carboplatin, paclitaxel, and radiotherapy on protocol VU-VICC-HN-0356
  PATIENT CHARACTERISTICS:
  -  Able to speak English
  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: Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants

Summary: RATIONALE: Collecting and storing samples of tissue, saliva, and blood from patients with cancer and from healthy participants to study in the laboratory may help the study of cancer in the future.
  PURPOSE: This research study is collecting and storing tissue samples from patients with head and neck cancer and from healthy participants.

Detailed description: OBJECTIVES:
  -  Maintain and update a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer.
  -  Develop a repository of biospecimens from these patients.
  OUTLINE: Tumor tissue samples and/or bronchial washings are collected from patients undergoing planned surgery and/or bronchoscopy, respectively. Buccal swabs and/or mouthwash samples and saliva samples are collected. Patients also undergo blood sample collection at baseline and then every 2-6 months thereafter.
  Healthy participants contribute blood samples, buccal swabs, and mouthwash samples at baseline only.
  Information about medical and family history and cancer risk factors is also collected.
  PROJECTED ACCRUAL: No limit.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Diagnosis of head and neck cancer
  -  Being treated at Vanderbilt University Medical Center for the cancer
  -  Healthy participant
  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: DNA Analysis of Tissue Samples From Patients With Head and Neck Cancer

Summary: RATIONALE: Studying samples of 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 laboratory study is looking at DNA in tissue samples from patients with head and neck cancer.

Detailed description: OBJECTIVES:
  -  Assess common genetic mutations in tumor and germline DNA samples from patients with head and neck squamous cell carcinoma (HNSCC).
  -  Search for viral DNAs and relate this information to demographics, tumor characteristics, and patient prognosis.
  -  Search for novel viral sequences and cancer-associated gene mutations in young nonsmoking HNSCC patients and in other distinct head and neck cancers.
  -  Determine tumor suppressor gene mutations in HNSCC patients and relate this information to gene expression data.
  -  Validate gene expression information using independent techniques such as real-time PCR on expressed sequences and immunohistochemistry.
  OUTLINE: Genetic mutation analysis and gene expression studies are performed on tissue samples from patients with head and neck squamous cell carcinoma. Techniques used include real time-PCR and immunohistochemistry.

Eligibility: Inclusion Criteria:
  -  Patient with head and neck squamous cell carcinoma (HNSCC) enrolled in the Head and Neck Tissue Repository
  -  Sufficient biological material collected to perform study tests
  -  Historical material available from excess tissues at the Vanderbilt Pathology Department
  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: Gene and Protein Expression Patterns in Predicting Response to Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer

Summary: RATIONALE: Studying samples of 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. It may also help doctors predict how will patients respond to treatment.
  PURPOSE: This research study is looking at gene and protein expression patterns in predicting response to cetuximab in patients with recurrent and/or metastatic head and neck cancer.

Detailed description: OBJECTIVES:
  -  To identify 100 patients from the Head and Neck Tumor Tissue Repository and Clinical Database treated with cetuximab monotherapy or cetuximab-containing combination therapy as a standard of care for recurrent and/or metastatic head and neck squamous cell carcinoma at Vanderbilt University Medical Center.
  -  To assay the diversity of gene and protein expression patterns seen in these patients.
  -  To identify predictive patterns associated with treatment response and survival of these patients by correlating the laboratory data with clinical data.
  OUTLINE: Tumor tissue specimens and clinical data are obtained from the Head and Neck Tumor Tissue Repository and Clinical Database protocol VU-VICC-HN-0356. Specimens are analyzed for patterns of gene and protein expression predictive of cetuximab treatment response and survival by DNA microarray, tissue microarray, reverse transcriptase-PCR, and mass spectroscopy.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of recurrent and/or metastatic head and neck squamous cell carcinoma
  -  Enrolled on the Head and Neck Tissue Repository and Clinical Database protocol VU-VICC-HN-0356
  -  Previously treated with cetuximab monotherapy or cetuximab-based combination therapy
  -  Sufficient biological material available for analysis
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant