araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Comparative Microarray Analysis in Primary Cutaneous Malignant Melanoma

Summary: Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). This study will be an exploratory analysis by miRNA expression profiling using microarrays.

Detailed description: Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). With regards to a rapidly growing number of newly discovered miRNA sequences, the availability of up-to-date miRNA expression profiles for primary cutaneous malignant melanoma (PCMM), cutaneous malignant melanoma metastases (CMMM) and benign melanocytic naevi (BMN) is limited. Patients with PCMM, CMMM and BMN are included in the study to perform an exploratory analysis by miRNA expression profiling using microarrays. Expression levels of miRNA candidates will be validated by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).

Eligibility: Inclusion Criteria:
  -  Primary Cutaneous Malignant Melanoma
  -  Cutaneous Malignant Melanoma Metastases
  -  Benign Melanocytic Naevi
  Exclusion Criteria:
  - Other Skin Cancer than Primary Cutaneous Malignant Melanoma

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma

Summary: The purpose of this study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with Ipilimumab alone

Detailed description: Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase: Randomized

Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
  Inclusion Criteria:
  -  Unresectable Stage III or Stage IV melanoma
  -  Part 1 Dose Escalation: Prior melanoma treatment allowed except for the following: ipilimumab, BMS-982470 (rIL-21), anti-Programmed Death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-PD-L2 or anti-CD137
  -  Part 2 Cohort expansion: Prior treatment for melanoma is not allowed, except for adjuvant therapy with interferon alpha or melanoma vaccines which are permitted
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
  -  Normal liver function tests
  Exclusion Criteria:
  -  Part 1 Dose escalation: subjects with ≤ 2 brain metastases of stable size, ≥ 4 weeks post-radiation treatment, and off steroids are allowed
  -  Part 2 Cohort expansion: subjects with known or suspected brain metastases and uveal melanoma are excluded
  -  Autoimmune disease

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Tissue and Blood Biomarkers From Patients With Stage III or Stage IV Melanoma Treated With Ipilimumab With or Without Sargramostim

Summary: RATIONALE: Studying samples of tissue and blood in the laboratory from patients treated with ipilimumab with or without sargramostim may help doctors learn more about the effects of ipilimumab and sargramostim on cells. It may also help doctors understand how well patients respond to treatment.
  PURPOSE: This research trial studies tissue and blood biomarkers in patients with stage III melanoma or stage IV melanoma treated with ipilimumab with or without sargramostim.

Detailed description: OBJECTIVES:
  -  To compare the pathology of primary melanomas, melanoma metastases, and post-treatment melanoma metastases in relation to clinical outcomes for patients receiving ipilimumab plus sargramostim (GM-CSF) and patients receiving ipilimumab alone.
  -  To determine the effects of the addition of systemic GM-CSF to ipilimumab on effector immune function in patients with metastatic melanoma.
  -  To determine the effects of the addition of systemic GM-CSF to ipilimumab on regulatory immune function in patients with metastatic melanoma.
  -  To determine the effects of the addition of systemic GM-CSF to ipilimumab on anti-tumor humoral immunity in patients with metastatic melanoma.
  OUTLINE: Serum, peripheral blood mononuclear cells, and tumor tissue (from primary tumor and post-treatment biopsies) samples are analyzed for biomarkers predictive of clinical outcomes, immune function, and anti-tumor humoral immunity by IHC, RT-PCR, flow cytometry, ELISPOT assays, and ELISA.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of measurable unresectable stage III or stage IV melanoma
  -  Treated with ipilimumab with or without sargramostim on clinical trial ECOG-E1608
  -  Primary tumor tissue and optional post-treatment biopsies of tumors from easily accessible tissues
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0 or 1
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

Summary: People with brain metastases from melanoma are offered different treatment options after local treatment of their brain metastases via surgery or stereotactic irradiation. Depending on the treating institution and the clinician involved a patient may or may not be offered whole brain radiotherapy (WBRT) after their brain metastases are excised or treated with stereotactic irradiation. This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT on quality of life and brain functions such as memory, speech and concentration. Participants will be randomised after local treatment of their brain metastases to either WBRT or observation. 220 people will be recruited from sites in Australia, Norway, the UK, the US and other international sites.


Eligibility: Inclusion Criteria:
  -  1-3 intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation.
  -  Life expectancy of at least 6 months
  -  Aged 18 years or older
  -  WBRT must begin within 8 weeks of completion of localised treatment and within 4 weeks of randomisation
  -  Able to have an MRI brain scan with contrast. Estimated Glomerular Filtrate Rate (eGFR) is adequate at the discretion of the radiologist and capable of having gadolinium-containing contrast medium for MRI as per practice guidelines
  -  Complete localised treatment of all these metastases no more than 6 weeks prior to randomisation
  -  An Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at randomisation
  -  CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation
  -  Serum Lactate Dehydrogenase (LDH) must be = or < 2 x upper limit of normal
  -  Able to provide written informed consent
  Exclusion Criteria:
  -  Any untreated intracranial disease
  -  Any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma
  -  Evidence of leptomeningeal disease on pre-local treatment MRI scan
  -  Patients with prior cancers, except:
  -  Those diagnosed more than five years ago with no evidence of disease recurrence within this time;
  -  Successfully treated basal cell and squamous cell skin carcinoma;
  -  Carcinoma in-situ of the cervix
  -  A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol
  -  Positive urine pregnancy test for women of childbearing potential within a week of registration onto the trial

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Metronomic Therapy in Patients With Metastatic Melanoma

Summary: SUMMARY: Metronomic Therapy in Patients with Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine.
  Patients with measurable metastatic melanoma are eligible. All patients will be treated as outlined below with combined vinblastine, cyclophosphamide, and dacarbazine. Patients will be treated continuously, until evidence of progression of disease, or for up to two cycles following disappearance of all disease. A cycle will be defined as three weeks of continuous therapy with a one week rest.

Detailed description: Low dose continuous chemotherapy, called metronomic chemotherapy, is designed to target vascular cells and inhibit tumor growth and metastasises. A recent study in a melanoma mouse model has identified low dose vinblastine, cyclophosphamide and dacarbazine as a treatment which improves the animal's survival and is superior to full dose dacarbazine alone. This clinical trial seeks to translate this laboratory model directly into metastatic melanoma patients.

Eligibility: -  Metastatic melanoma with measurable disease
  -  Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or chemotherapy (6 weeks for nitrosoureas) and recovered from all ill
  -  Karnofsky Performance Status ≥60%
  -  Life expectancy ≥ twelve weeks
  -  Adequate end organ function
  -  Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study.
  -  Appropriate Contraception in both sexes
  -  The patient must be competent and signed informed consent.
  EXCLUSION CRITERIA
  -  Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence, breast CIS.
  -  In patients with a prior history of invasive malignancy, less than five years in complete remission.
  -  Have evidence of significant co-morbid illness such as uncontrolled diabetes - Uncontrolled brain metastasis: Patients with brain metastasis most have been treated with brain radiation therapy or surgery and remain clinically stable for a minimum of 4 weeks.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: A Clinical Trial to Assess the Safety & Efficacy of the Treatment of Patients With Metastasis From Malignant Melanoma - Treatment Consists of the Substances Lomustine (Capsules) & Cytarabine (Injected Into an Area Near the Spinal Cord), Accompanied by Radiotherapy of the Brain

Summary: The purpose of this trial is to test the safety and tolerance of the combination therapy with cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from malignant melanoma.


Eligibility: Inclusion Criteria:
  -  Malignant melanoma (including melanoma of unknown primary site, recurrent and pretreated systemic melanoma and/or melanoma with parenchymal CNS metastases) with leptomeningeal metastasis as demonstrated by a positive CSF (cerebrospinal liquor) cytology AND/OR by the presence of characteristic signs and symptoms of leptomeningeal metastasis supported by an MRI scan indicating the presence of meningeal tumour
  -  CSF flow abnormalities must be excluded
  -  Males or females ≥ 18 years of age
  -  Karnofsky Performance Status > 50%
  -  Adequate organ function (adequate bone marrow reserve, adequate liver function, adequate renal function. adequate blood clotting)
  Exclusion Criteria:
  -  Unresected parenchymal brain metastases with a diameter > 3 cm
  -  Prior non melanoma malignancy (unless adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
  -  Prior intrathecal chemotherapy
  -  Prior treatment with systemic cytarabine or nitrosureas
  -  The patient ist pregnant or breast feeding
  -  Severe, active co-morbidities

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma

Summary: Circulating tumor cells (CTC) are the subject of increasing interest in clinical oncology as a prognostic factor and predictor of therapeutic response. The detection of CTC by immunomagnetic method has proved its reliability and its usefulness for monitoring breast cancer, colon and prostate in the metastatic and immunomagnetic detection system (CellSearch, Veridex LLC) was approved by the FDA in these indications. However, to date there is no reliable method to detect CTCs in melanoma (CMC). Studies based on PCR amplification of mRNA by reverse specific melanoma is disappointing. Recently, a new detection system of CMC immunomagnetic was presented (CellSearch, Veridex LLC, United States). This system has the advantage of combining immunomagnetic selection step and a step of identifying by immunofluorescence. A preclinical study on serial dilutions of melanoma cells has shown encouraging results. The investigators propose a prospective study of the CellSearch system in patients with melanoma.
  Primary objective: To determine the effect of treatment on the number of circulating melanoma cells in patients with metastatic melanoma.
  Secondary objectives:
  -  determine the percentage of patients with metastatic melanoma with melanoma cells circulating
  -  seek a relationship between the number of circulating melanoma cells and prognosis in patients with metastatic melanoma
  -  seek a relationship between the change in the number of circulating melanoma cells before / after treatment and tumor response in patients with metastatic melanoma


Eligibility: Inclusion Criteria:
  -  Patients > or = 18 years
  -  Patients with advanced melanoma stage IIIC (unresectable) or stage IV
  -  Patient not treated or not responding to chemotherapy with chemotherapy session last> 1 month
  -  Patients who signed informed consent
  -  Patients presenting no socio-economic, psychological, familial or geographical allow proper understanding of the information leaflet of the protocol or the regular monitoring in the department of dermatology
  -  Patients with a life expectancy greater than 3 months
  -  Patients with melanoma measurable by RECIST version 1.1
  -  Patients with venous good for venipuncture
  Exclusion Criteria:
  -  Patients with contraindication for treatment with chemotherapy or V600E BRAF inhibitor or ipilimumab or have conditions concomitant heavy may interfere with the treatment of metastatic melanoma
  -  Pregnant women or nursing
  -  People vulnerable detainees, adults under guardianship or curatorship, minors.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Endoscopic Band Ligation Versus Argon Plasma Coagulation for the Treatment of Gastric Antral Vascular Ectasia: a Randomized Clinical Trial

Summary: The investigators goal is to compare the standard argon plasma coagulation (APC) treatment with endoscopic band ligation (EBL) in patients with Gastric Antral Vascular Ectasia.

Detailed description: Gastric antral vascular ectasia (GAVE) is a vascular structural malformation in the stomach that can lead to active or chronic intermittent gastrointestinal bleeding or chronic iron-deficiency anemia.
  The current standard endoscopic treatment is with APC. There have been multiple reports and case series in the literature about successful treatment with EBL for GAVE, even in cases where APC was unsuccessful for treatment of GAVE. Our goal is to compare the standard APC treatment with EBL in patients with Gastric Antral Vascular Ectasia.

Eligibility: Inclusion Criteria:
  -  Consecutive patients with GAVE identified at endoscopic examination, patients may have active GI bleeding, chronic anemia or drop in hemoglobin levels.
  Exclusion Criteria:
  -  Patients with previous endoscopic treatment for GAVE within the last 3 months, patients with GAVE without chronic anemia or active bleeding, patients in whom another possible source of GI bleeding is found

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Summary: Melanoma is nowadays an important public health problem because its growing incidence. Mass screening for melanoma is not recommended worldwide because of its low cost-effectiveness. Nevertheless targeted screening for patients at high risk for melanoma is promoted. This study is designed to assess the effectiveness and the acceptability of a melanoma targeted screening of melanoma, to estimate the risk function to develop a melanoma among patients at high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk according to the SAMScore were proposed a skin examination by their GP every year.


Eligibility: Inclusion Criteria:
  -  patients more than 18 years old,
  -  consulting their GP,
  -  assessed at risk for melanoma according to the SAMScore
  -  signed the consent.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Combined Therapy in Radiation Proctopathy

Summary: The aim of this study was to compare the efficacy and safety of two treatment regimens: argon plasma coagulation (APC) alone and APC in combination with sucralfate administered for chronic hemorrhagic radiation proctopathy.

Detailed description: Chronic radiation proctopathy (CRP) or proctosigmoiditis is a late complication of pelvic radiotherapy. Symptoms, including diarrhea, rectal bleeding, urgency, and tenesmus, are difficult to treat and adversely impact patient quality of life. Various treatments directed at the reduction of blood loss and improvement of other symptoms have been evaluated, with the most encouraging results reported for two methods: endoscopic argon plasma coagulation (APC) of radiation-induced abnormal vessels in the rectal mucosa, and administration of sucralfate, a drug believed to enhance the mucosal defense and healing when administered orally or rectally. Adequately powered randomized trials comparing various treatments are lacking, and an optimal management strategy has yet to be determined. To address this issue, we conducted a single-center, randomized, placebo-controlled, double-blind study comparing the efficacy and safety of APC alone and APC in combination with sucralfate administered orally.

Eligibility: Inclusion Criteria:
  -  radiotherapy due to pelvic tumors completed at least three months prior to enrollment
  -  presence of rectal bleeding
  -  radiation-induced telangiectasia in the rectum and/or sigmoid colon on endoscopy
  -  informed written consent to participate in the study
  Exclusion Criteria:
  -  history of clinically significant rectal bleeding prior to radiotherapy
  -  conditions predisposing the patient to rectal bleeding including inflammatory bowel disease, tumors of the large bowel, intestinal vascular lesions (other than radiation-induced telangiectasia), and diversion of the fecal stream
  -  sucralfate treatment during the two weeks prior to enrollment
  -  renal insufficiency (creatinine level ≥2 mg/dl)
  -  concurrent chemotherapy
  -  concurrent therapy with tetracycline, fluoroquinolones, or antimycotic drugs (because of drug interaction)
  -  concurrent therapy with oral anticoagulants

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

Summary: This study is being done to evaluate single incision laparoscopic surgery (SILS) for colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended to standardize the SILS technique for colorectal diseases

Detailed description: PRIMARY OBJECTIVES:
  I. To report the experience of SILS procedure in the treatment of colorectal disease.
  II. To standardize the SILS technique.
  OUTLINE:
  Patients undergo single incision laparoscopic surgery with GelPort® attachment.
  After completion of study treatment, patients are followed up at 2 weeks, 3 and 6 months, and at 1 year.

Eligibility: Inclusion Criteria:
  -  Patients who are willing to give consent and comply with the evaluation and the treatment schedule
  -  Patients with disease processes limited to the right colon; this will include Crohn's disease, polyp disease, and cancers of the right colon
  -  American Society of Anesthesiologists (ASA) =< 3
  Exclusion Criteria:
  -  Inability to obtain informed consent
  -  Previous right colon surgery
  -  Previous extensive abdominal surgery that would limit the laparoscopic approach
  -  Stage IV disease at surgery
  -  Metastatic disease diagnosed by computed tomography (CT), magnetic resonance imaging (MRI), or nuclear imaging
  -  Patient enrolled in other interventional study
  -  ASA score greater than 3
  -  Any condition which precludes compliance with the study (Investigator discretion)
  -  Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: A Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy and Safety of Single Agent GS 1101 (CAL 101) as Therapy for Previously Treated Chronic Lymphocytic Leukemia

Summary: The purpose of this study is to evaluate the effect of GS-1101 on the onset, magnitude, and duration of tumor control

Detailed description: This is a Phase 2, multicenter, single-arm, controlled, clinical trial evaluating the efficacy and safety of the phosphatidylinositol 3-kinase delta (PI3K-delta) inhibitor GS-1101 (CAL-101) as therapy for previously treated chronic lymphocytic leukemia.
  This clinical trial (Study GS-US-312-0120) is a single-arm in which compliant subjects from GS US-312-0119 -Arm B who experience progression of CLL while receiving single-agent ofatumumab therapy are potentially eligible to receive single-agent, open-label GS 1101 therapy.

Eligibility: Inclusion Criteria:
  -  Participation in Study GS-US-312-0119
  -  Occurrence of confirmed progression of CLL while receiving single-agent ofatumumab in Study GS US 312 0119.
  -  Permanent cessation of Study GS-US-312-0119 (single-agent ofatumumab) and no intervening or continuing therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of CLL.
  -  The time from permanent cessation of single-agent ofatumumab on Study GS-US-312-0119 and the initiation of GS 1101 on Study GS-US-312-0120 is no more than 12 weeks.

Relevance to patient case: not relevant