araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Photodynamic Therapy in Treating Patients With Skin Cancer

Summary: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in treating patients with skin cancer.
  PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that includes aminolevulinic acid works in treating patients with skin cancer.

Detailed description: OBJECTIVES:
  -  Determine the efficacy of aminolevulinic acid and laser irradiation in patients with superficial and nodular epidermally derived lesions.
  OUTLINE: This is a randomized study. Patients are stratified according to lesion type (superficial basal cell carcinoma [BCC] vs nodular BCC vs superficial squamous cell carcinoma vs actinic keratoses). Individual lesions on patients within each stratum are randomized to receive either a 4-5 or 18-24 hour application of aminolevulinic acid (ALA).
  ALA is topically applied in a cream mixture and an occlusive dressing is placed over the lesion. After the randomized duration of ALA application has expired, the dressing is removed and a dye laser is used to treat the lesion.
  Patients are followed for 2-5 years after treatment.
  PROJECTED ACCRUAL: Up to 200 patients could be accrued, assuming 1 lesion per patient. 50 lesions are required for each stratified group.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following:
  -  Actinic keratoses
  -  Histologically proven superficial or nodular basal cell carcinoma (BCC), squamous cell carcinoma in situ (Bowen's disease), or microinvasive squamous cell carcinoma
  -  No nodular BCC greater than 4 mm thick that will not be surgically removed
  -  No carcinoma with uncertain margins requiring Moh's surgery
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  No known photosensitivity disease
  -  No porphyria or hypersensitivity to porphyrins
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Not specified
  Surgery:
  -  Not specified
  Other:
  -  No prior treatment with systemic photosensitizer that would cause residual cutaneous photosensitivity during study participation

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Assessment of Digital Imaging as a Tool for Diagnosing Psoriasis, Hand Rashes and Unusual Moles

Summary: This study will evaluate whether digital photography is a reliable tool for diagnosing hand rashes, psoriasis and unusual moles. The findings will help determine if this method can be used in the National Health and Nutrition Examination survey (NHANES), which monitors disease in the United States.
  Employees of the National Institutes of Health 19 years and older may enroll in this study. Participants will complete a brief questionnaire that includes information on skin type, history of skin conditions (moles, cancer, rashes, psoriasis), and demographic information such as name, age and sex. They will be examined by a dermatologist, who will note in writing the appearance of any hand rashes, unusual moles, or psoriasis. If any areas suspicious for skin cancer are found, the participant will receive this information in writing, along with advice about where to go for treatment.
  A total of six photographs will then be taken of the participant's arms, legs, hands and back. The face will not be photographed, and the participants will not be identifiable.

Detailed description: This validation study is designed to evaluate the sensitivity, specificity, validity and reliability of digital photography of the skin as a prevalence assessment tool in preparation for the National Health and Nutrition Examination Survey, 2001 (NHANES IV). NHANES is charged with monitoring disease in the U.S. population, which is affected frequently by skin disorders and disease. The three skin disorders proposed for study in NHANES IV are atypical nevi, psoriasis, and hand dermatitis. This selection is based on the expected impact of these diseases on the U.S. population, including a prevalence of 3-10%, associated risk of melanoma in the case of atypical nevi, and associated disability in the cases of psoriasis and hand dermatitis.
  This skin disease section of NHANES, as currently planned for 2001, includes an imaging component with four standardized photographs to be obtained from each survey participant (SP). The selection of the regions to be photographed is designed to maximize the information obtained, while preserving patient privacy and is based on the known distribution of clinical findings of the three conditions, as well as NHANES logistical limitations. This validation study is a cooperative effort between the NIAMS extramural programs, the NCI intramural program, and the National Center for Health Statistics.

Eligibility: Must have employee status at the National Institutes of Health.
  Age greater than 18 years.
  Able to understand and sign consent.
  Patients who are wheelchair bound and are unable to have images of their back and lower extremities taken safely will be excluded from photography since this portion of the examination requires an ability to stand. However, they will still be eligible to participate in the skin cancer screening.

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer

Summary: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage IV colorectal cancer. Imatinib mesylate may interfere with the growth of tumor cells by blocking certain enzymes necessary for cancer cell growth

Detailed description: PRIMARY OBJECTIVES:
  I. To determine response to Gleevec (Imatinib Mesylate) in patients with metastatic colorectal cancer and with c-Kit, Arg, Abl, or PDGF-R expression.
  II. To determine the side effects of Imatinib Mesylate in patients with colorectal cancer.
  III. To study the biologic effects of Imatinib Mesylate on the c-Kit and PDGF-R system and downstream signaling in metastatic colorectal cancer.
  OUTLINE:
  Patients receive oral imatinib mesylate twice daily. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better continue therapy until disease progression or 1 year after complete response.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IV colorectal cancer
  -  Arg, KIT (CD117), or PDGF-R expression (1+ in 20% of cells) in the tumor or microvasculature
  -  At least one unidimensionally measurable lesion
  -  At least 10 mm by spiral CT scan
  -  No known brain metastases
  -  Performance status - ECOG 0-2
  -  Performance status - Karnofsky 60-100%
  -  At least 12 weeks
  -  Granulocyte count at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  -  Bilirubin no greater than 2.0 mg/dL
  -  AST/ALT less than 2.5 times upper limit of normal
  -  Creatinine no greater than 2.0 mg/mL
  -  No symptomatic congestive heart failure
  -  No unstable angina pectoris
  -  No cardiac arrhythmia
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective barrier contraception during and for 3 months after study participation
  -  No other malignancy within the past 3 years except non-melanoma skin cancer or carcinoma in situ of the cervix
  -  No concurrent uncontrolled illness
  -  No ongoing or active infection
  -  No psychiatric illness or social situation that would preclude study compliance
  -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  -  More than 4 weeks since prior radiotherapy and recovered
  -  More than 3 weeks since prior surgery (excluding diagnostic biopsy)
  -  No other concurrent investigational agents
  -  No concurrent therapeutic doses of anticoagulants (e.g., warfarin)
  -  No concurrent grapefruit
  -  No concurrent combination antiretroviral therapy for HIV-positive patients

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Phase II Trial of Allovectin-7® for Metastatic Melanoma

Summary: The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this treatment can improve the time to disease progression.

Detailed description: Treatment - If you take part in this trial you will be treated for about 10 weeks. You will receive an injection of Allovectin-7® by needle, directly into one or more selected tumors once a week for the first six weeks. The injections may be given in a doctor's office. During a four-week observation period, your disease will be measured to see if the treatment is working. This will be done by general physical exams and scans (such as X-ray scans). Patients who show no sign of disease progression may be offered an option to repeat this treatment course.

Eligibility: In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria.
  -  You have been diagnosed with Stage III or Stage IV melanoma
  -  Your cancer has returned after a prior treatment (e.g. radiation or chemotherapy) or you refused therapy with standard treatment
  -  You are able to carry out your normal daily activities
  -  Your melanoma has not spread to your brain

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine

Summary: In this study, a melanoma vaccine (5 melanoma peptides) is given with either Montanide or dendritic cells as adjuvants. This randomized trial will establish the safety of both vaccines and compare the 2 vaccine adjuvants in their efficacy to induce immune responses.

Detailed description: In this study, we will examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens in melanoma patients who are clinically free of disease but at high risk for recurrence. This vaccine will be compared to direct injection of the same peptides with KLH and Montanide as adjuvant.

Eligibility: Inclusion Criteria:
  -  Resected stage IIB, IIC, or stage III melanoma.
  -  Fully recovered from surgery
  -  Human leukocyte antigen (HLA) A*0201 positive.
  -  Age >18 years.
  -  Karnofsky performance status: >80% and normal labs.
  Exclusion Criteria:
  -  Prior chemotherapy.
  -  Known chronic infection with HIV, hepatitis B or C.
  -  Patients with known autoimmune disease [e.g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA)]. Patients with vitiligo are not excluded.
  -  Pregnant women.
  -  Patients with known allergy to gentamicin, tobramycin, streptomycin and amikacin (risk of cross-reaction between aminoglycosides).
  -  Patients who have known retinal or choroidal eye disease.
  -  Patients previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with Montanide are not eligible.
  -  Allergy to shellfish.

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Vaccine Therapy in Treating Patients With Malignant Melanoma

Summary: RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells.
  PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.

Detailed description: OBJECTIVES:
  -  Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™).
  OUTLINE: This is an open-label, multicenter study.
  Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of response at week 24 receive no further treatment. Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine (Canvaxin™).
  After completion of study treatment, patients are followed at 30 days.
  PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed malignant melanoma
  -  At least 1 in-transit skin lesion measuring 3-10 mm in the longest diameter
  PATIENT CHARACTERISTICS:
  Age
  -  18 to 80
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Multiepitope Peptide Vaccination in Melanoma

Summary: This trial assesses the clinical efficacy of a multiepitope peptide vaccine with GM-CSF and KLH as immunological adjuvants in stage IV melanoma patients


Eligibility: Inclusion Criteria:
  -  Metastatic melanoma
  -  HLA-A1, -A2, -A24, -B44
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes

Summary: This trial is for various types of malignancies which may depend on certain enzymes (tyrosine kinases) for growth. The objective of this study is to assess to what extent imatinib mesylate blocks these enzymes and to assess the effect on the malignancy.

Detailed description: Condition
  Diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocytic leukaemia, dermatofibrosarcoma protuberans and other diseases.
  Not included:
  Patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some types of gastrointestinal stromal tumours (c-KIT-positive), some systemic mastocytosis (if c-KIT D816V mutation), brain, prostate, breast or lung cancers.

Eligibility: Inclusion Criteria:
  1. Malignancy likely related to an activated tyrosine kinase enzyme sensitive to imatinib mesylate.
  2. Spread of the disease to the rest of the body (confirmed by tissue sample) beyond the skin.
  3. Malignant tissue showing activation of certain tyrosine kinases (ABL, ARG, KIT (CD117), or PDGF-R alpha or beta) & preferably within 6 weeks of entry.
  Exclusion Criteria:
  1. Certain leukaemias (abl-mutated), some gastrointestinal stromal tumours (c-KIT-positive) or certain systemic mastocytosis (if c- KIT D816V mutation).
  2. A primary prostate, breast, lung or brain tumour,
  3. Patient has previously been treated with imatinib mesylate except where treatment was more than 6 months previously and there is no suggestion of clinical resistance nor lack of response.
  Other protocol-defined inclusion / exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Efficacy of Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Progressive Soft Tissue Metastases

Summary: The incidence of malignant melanoma continues to rise throughout the world. Approximately 12 in 100,000 Germans are diagnosed with malignant melanoma per year. Malignant melanoma is often very aggressive since it may spread both through the lymphatic system and the bloodstream at an early stage of disease.
  While treatment of localized disease is mostly surgical, in patients with extensive disease, prognosis remains poor; the primary standard therapy of metastastic disease comprises dacarbazine (DTIC) eventually combined with other chemotherapeutic agents e.g., cisplatin or BCNU. The duration of response to systemic chemotherapy is generally short and so far, no standard second-line treatment has been established.
  To study the potential additional therapeutic effects of regional hyperthermia in advanced malignant melanoma patients with progressive chemotherapy refractory soft tissue metastases, in the present trial, we sought to compine local hyperthermia with concomitant systemic second-line chemotherapy.


Eligibility: Inclusion Criteria:
  -  age between 18 and 70
  -  histologically proven malignant melanoma with advanced inoperable soft tissue metastases
  -  progressive disease upon systemic first-line chemotherapy
  -  2 or more bidimensionally measurable soft tisue lesions
  -  WHO performance status (ECOG) of 2 or more
  -  life expectancy of 8 weeks and more
  -  prior informed consent
  Exclusion Criteria:
  -  participation in other therapy studies
  -  pregnancy or breast feeding
  -  concomitant clinically significant infection
  -  cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region (including a safe distance of 5 cm)
  -  lack of physiological heat sensitivity within the hyperthermia treated region (including a safe distance of 5 cm)

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Neural Changes in the Aging Auditory System

Summary: The purpose of this study was to determine the effects of hormone replacement therapy (HRT) on hearing in post-menopausal women.

Detailed description: Background: Female hormone influences on the development and aging of the auditory system are not completely understood. The present study retrospectively analyzed and compared hearing abilities among post-menopausal women taking hormone replacement therapy (HRT), treated with estrogen and progesterone (E+P); estrogen alone (E), and a third (control - NHRT) group, matched for age, who did not receive any HRT.
  Methods: 126 subjects, (60-86 yr), N=32, E+P; N=31, E; N= 63, NHRT; matched for age and health status participated. All had relatively healthy medical histories, absence of significant noise exposure, middle ear problems, major surgeries or current/heavy smoking. Hearing tests included pure tone audiometry (PTA), tympanometry, distortion-product otoacoustic emissions (DPOAEs), transient otoacoustic emissions (TEOAEs) and hearing-in-noise-test (HINT). The latter is a test for speech perception in background noise: the major complaint of hearing-impaired persons.

Eligibility: Inclusion Criteria:
  -  Healthy middle ears
  Exclusion Criteria:
  -  ototoxic medications
  -  serious medical health problems
  -  neurological conditions
  -  Meniere’s disease or labyrinthitis
  -  those who failed cognitive screening tests (Mini-Mental Test)
  -  current/heavy smokers
  -  conductive hearing loss
  -  history of noise damage and/or audiograms signifying noise damage
  -  poor speech discrimination scores (80% or less)

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes

Summary: This trial seeks to establish the role of post-operative radiotherapy in patients who have had surgery for melanoma involving lymph nodes and who are at high risk of recurrence.

Detailed description: This is a randomised phase III trial which is being performed on patients at high risk of local recurrence after having a lymphadenectomy for stage 3 melanoma. The control arm is surgery alone with radiotherapy reserved for those who recur. The study arm is surgery plus post-operative radiotherapy. All 3 major node sites are eligible. The radiation dose administered is 48Gy in 20 fractions. It is likely to be the only study of its kind ever performed. The target is 230 patients.

Eligibility: Inclusion Criteria:
  -  Regional macroscopic nodal metastatic melanoma in one nodal basin region only which has been completely resected.
  -  melanoma involving lymph nodes at high risk of local recurrence (details in protocol)
  -  No evidence of metastases
  -  No active major cancer within 5 years
  -  Normal blood tests
  -  WHO performance status of 0 or 1
  -  Radiotherapy must be able to be commenced within 12 weeks of lymphadenectomy
  -  Patient must not be pregnant and if fertile must use a medically acceptable contraceptive throughout treatment
  -  No major concurrent illnesses likely to cause death within 2 years
  -  Written informed consent has been given
  Exclusion Criteria:
  -  Evidence of active or previous local recurrence or in transit disease
  -  Evidence of distant metastases on clinical or radiological investigation
  -  Patients with prior cancers

Relevance to patient case: not relevant