araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC

Summary: The study aims to explore the prevalence of ALK/ROS1/MET mutations assessed with ctDNA samples in EGFR-wildtype NSCLC


Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IIIB/IV NSCLC;
  -  Histologically confirmed adenocarcinoma;
  -  EGFR-wildtype NSCLC;
  -  Provision of blood (plasma) sample for ctDNA testing;
  -  Patient must be able to comply with the protocol;
  -  Provision of blood (plasma) sample for ctDNA testing;
  Exclusion Criteria:
  -  As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
  -  Histologically confirmed small cell lung cancer or other metastatic tumors;
  -  Patient with no histologic or cytological diagnosis;

Relevance to patient case: definitely relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Skeletal Muscle Atrophy and Dysfunction in Human Cancer

Summary: Cancer and its treatment can have profound effects on skeletal muscle, the most well-recognized being atrophy, weakness and diminished oxidative capacity. These adaptations negatively impact quality of life, treatment decisions and survival. Despite these consequences, the factors promoting these adaptations remain poorly defined and understudied in human patients. To address this gap in knowledge, our goal in this study is to examine the role of muscle disuse as a regulator of muscle size and function in human cancer patients


Eligibility: Inclusion Criteria:
  -  50-75 yrs of age
  -  histologically-documented, stage III or IV non-small cell lung carcinoma (NSCLC)
  -  estimated life expectancy >6 mos
  -  Karnofsky's performance score of ≥70
  Exclusion Criteria:
  -  history, signs or symptoms of inflammatory or autoimmune disease
  -  uncontrolled hypertension
  -  heart or renal failure
  -  exercise limitations from peripheral vascular disease or stroke
  -  neuromuscular disease
  -  knee/hip replacement
  -  additional, actively-treated malignancy or history of malignancy, except non-melanoma skin cancer
  -  taking medication that can have anti-coagulant effects that cannot be stopped prior to the muscle biopsy

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy

Summary: A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy


Eligibility: Inclusion Criteria:
  -Histologically or cytologically confirmed unresectable locally advanced NSCLC with progressed or recurred after no more than four previous docetaxel-free chemotherapy regimens, or unresectable locally advanced or metastatic SCCHN or recurred after previous docetaxel-free chemotherapy regimens
  Exclusion Criteria:
  1. Women who are nursing or pregnant during the study period;
  2. Patients with carcinoid tumors, small-cell carcinoma of the lung;
  3. A history of another malignancy within the last five years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the uterine cervix);
  4. Any other morbidity or situation with contraindications for chemotherapy (e.g. active infection, myocardial infarction in the preceding 6 months);
  5. Neutrophil counts < 1,500 cells/mm3;
  6. A history of hypersensitivity to docetaxel or cisplatin;
  7. Symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias;
  8. Subjects have active hepatitis;
  9. Subjects are known positive for Human Immunodeficiency Virus (HIV);
  10. Any condition judged by investigator, participates the study will jeopardize patient's wellbeing

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer

Summary: The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with pemetrexed alone in advanced non-small cell lung cancer patients in the second or second line of treatment of progression-free survival

Detailed description: It is a one-arm study. The progression-free survival will be evaluated.

Eligibility: Inclusion Criteria:
  1. Aged from 18 years to 70years.
  2. Histologically or cytologically confirmed non-squamous non-small cell lung cancer(stage IIIB/IV).
  3. Measurable lesions as defined by RECIST criteria.
  4. Locally advanced lung cancer cannot treat with surgery, recurrent or metastatic lung cancer
  5. ECOG performance status (PS) of 0 to 1.
  6. Life expectancy ≥3 months.
  7. Informed consent.
  Exclusion Criteria:
  1. Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
  2. Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
  3. Tumor invade big vessels or close to big vessels (less than 5mm)
  4. Obvious cavity or necrosis formed in the tumor
  5. Uncontrolled hypertension
  6. Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
  7. Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy
  8. The active HBV or HCV infection
  9. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.
  10. Hemoptysis, more than 2.5ml daily
  11. Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
  12. Unhealed bone fracture or wound for long time
  13. Received big surgery, had bone fracture or ulcer in 4 weeks.
  14. Urine protein≥++, or urine protein in 24 hours≥1.0g
  15. Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment
  16. Have received prior treatment with VEGFR TKI (Bevacizumab is permitted).
  17. Pregnant or lactating woman, or woman unwilling to practice contraception during the study.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China

Summary: To evaluate the concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact of the relative abundance of sensitizing / resistance mutations.

Detailed description: In the study, 500 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and circultating tumor DNA (ctDNA) liquid biopsy. Patients who carry actionable EGFR mutation, ROS1 fusion, ALK fusion or MET exon 14 skipping mutation will receive TKI treatment according to guidelines. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. The study will be ended when all the patients had a progressive disease (PD) in their targeted lesion.

Eligibility: Inclusion Criteria:
  -  Provision of informed consent
  -  Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively
  -  ECOG performance status 0-2 with expected more than 6 months of survival time
  -  Willingness to comply with required protocols and give permission to use the data for clinical research and products development
  Exclusion Criteria:
  -  Patients have other primary cancers
  -  Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders
  -  Patients failed in either plasma or tissue sample QC

Relevance to patient case: definitely relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Savolitinib vs. Sunitinib in MET-driven PRCC

Summary: This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if an investigational new anti-cancer medication, savolitinib, is effective in treating patients with MET-driven PRCC, how it compares with another medication frequently used to treat this disease called sunitinib, and what side effects it might cause.


Eligibility: Inclusion Criteria:
  1. Histologically confirmed Papillary Renal Cell Carcinoma, which is unresectable and locally advanced or metastatic with measurable disease as per RECIST 1.1.
  2. Confirmation of MET-driven PRCC without co-occurring Fumarate Hydratase or Von Hippel Lindau mutations from a tumour sample using the sponsor-designated central laboratory validated MET Next Generational Sequencing assay
  3. Patients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC. Patients who have received prior therapy must have had disease progression within 6 months of the last dose of previous systemic therapy
  4. Adequate haematological, renal (creatinine < 2xULN), cardiac and liver functions
  5. Karnofsky performance status ≥ 80
  6. Ability to swallow oral medicines.
  Exclusion Criteria:
  1. Most recent cytotoxic chemotherapy, immunotherapy, chemo-immunotherapy, or investigational agents <21 days from the date of randomisation or 5 half-lives of the agent, whichever is longer. Most recent non-cytotoxic targeted therapy <14 days from the date of randomisation.
  2. Prior treatment with a MET inhibitor (e.g. foretinib, crizotinib, cabozantinib, onartuzumab or previous savolitinib) or sunitinb.
  3. Treatment with strong inducers or inhibitors of CYP3A4 or strong inhibitors of CYP1A2, taken within 2 weeks or not possible to be stopped for at least 2 weeks before the date of randomisation.
  4. History of serious liver disease
  5. Serious active infection or gastrointestinal disease
  6. Uncontrolled hypertension (BP ≥150/95 mmHg despite medical therapy)

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Study to Assess Programmed Death Ligand-1 (PD-L1) Expression in Cytological Versus Histological Lung Cancer Specimens

Summary: The primary purpose of this non-interventional, multinational study is to assess the feasibility of assessing PD-L1 protein expression on cytological samples as a surrogate for histological samples obtained from participants with any stage of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).


Eligibility: Inclusion Criteria:
  -  Samples must have been collected in a manner that is compliant with local ethics committee guidance
  -  Samples must originate from participants diagnosed with NSCLC or SCLC
  -  Participants must have a pair of at least one cytological and one histological specimen that: Both originate from inside the thorax or from the same ex-thoracic site; Are confirmed to have been collected within a window no more than 6 weeks apart from each other; and are in compliance with the protocol defined sample requirements for histological and cytological specimens
  Exclusion Criteria:
  -  Immune checkpoint inhibitor therapy from 4 weeks prior to collection of the first tumor sample until collection of the second matched sample

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Efficacy and Safety of Sorafenib as Adjuvant and Latter Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma

Summary: Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study.

Detailed description: Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study. Eligible cases will be assigned into the experimental group and the control group. For experiment group, sorafenib tablet will be given for two weeks, and then perform radiofrequency ablation. For the control group, RFA will be performed immediately.

Eligibility: Inclusion Criteria:
  -  Aged from 18 to 75 years old
  -  Without gender restriction
  -  With a favorable liver function of Child-Pugh A to B
  -  No contraindications to RFA and anesthesia
  -  Diagnosed with Recurrent HCC
  -  Signed informed consent.
  Exclusion Criteria:
  -  Cancer thrombosis in major vessels/ extrahepatic metastasis
  -  Uncontrollable ascites or variceal bleeding
  -  Impairment in liver function
  -  Severe disorders in vital organ
  -  Accompanied with other tumors or infectious disease except hepatitis.

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients with liver or bile duct cancer.

Detailed description: OBJECTIVES: I. Determine the response rate and toxicity of doxorubicin HCl liposome in patients with carcinomas of the liver and bile ducts.
  OUTLINE: Patients receive doxorubicin HCl liposome IV over 15 minutes every 21 days. Filgrastim (G-CSF) is administered subcutaneously starting on day 2 and continuing for 10-14 days. Disease is restaged after every 3 courses. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first year, and then every 6 months thereafter.
  PROJECTED ACCRUAL: There will be 17-26 evaluable patients accrued into this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the liver or bile ducts including hepatocellular carcinoma, cholangiocarcinoma, and gallbladder cancer Measurable or evaluable disease by CT scan (ascites, pleural effusions, and bone metastases are not considered evaluable)
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3 mg/dL No severe cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: Left ventricular cardiac ejection fraction at least 45% Other: No allergy to egg or egg products Not pregnant or nursing Effective contraception required of all fertile patients
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior doxorubicin At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Not specified

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas

Summary: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for cancer of the bile duct, gallbladder, or pancreas.
  PURPOSE: Phase II trial to determine the effectiveness of photodynamic therapy in treating patients who have cancer of the bile duct, gallbladder, or pancreas.

Detailed description: OBJECTIVES: I. Determine the safety and efficacy of photodynamic therapy using porfimer sodium in patients with unresectable malignant bile duct obstruction.
  OUTLINE: Patients are stratified according to tumor location (proximal vs distal). Patients receive porfimer sodium IV over 3-5 minutes on day 1, followed by percutaneous or endoscopic laser light treatment on day 3. Patients achieving partial response or complete response accompanied by an increase in total bilirubin or cholangitis may repeat treatment for a maximum of 3 courses. Patients are followed weekly for 1 month, and then monthly for 1 year.
  PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven malignant bile duct obstruction with obstructive jaundice Primary carcinoma of bile duct, gallbladder, or pancreas OR Metastatic bile duct disease Successful insertion of a percutaneous drain or endoscopic stent Unresectable disease OR Resectable disease but refusal of surgery Prior biliary plastic or metallic stent allowed, if requiring stent replacement due to recurrent jaundice or routine plastic stent change No erosion of biliary tumors into major blood vessels No evidence of bile duct perforation
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin at least 2 mg/dL Renal: Not specified Other: No history of allergies or hypersensitivity to porphyrins No porphyria No cholangitis or pancreatitis
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy or brachytherapy to the abdomen Surgery: See Disease Characteristics Other: No other prior or concurrent experimental or investigational drugs

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis

Summary: OBJECTIVES:
  I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients self-administer daily subcutaneous injections of human parathyroid hormone (1-34) or placebo for a period of 2.5 years.
  Patients are followed regularly for unacceptable toxicities.
  Completion date provided represents the completion date of the grant per OOPD records

Eligibility: PROTOCOL ENTRY CRITERIA:
  --Disease Characteristics--
  Osteoporosis as defined by: Bone mineral density at the lumbar spine or femoral neck that is 2.5 standard deviations below peak bone mass reference value (T score less than -2.5)
  No family history of male osteoporosis
  No other metabolic bone disease
  --Prior/Concurrent Therapy--
  Endocrine therapy:
  -  No concurrent glucocorticoid therapy
  -  No prior steroid use
  Surgery: No prior gastrointestinal tract surgery
  Other: No prior or concurrent anticonvulsant therapy
  --Patient Characteristics--
  Hematopoietic: Normal CBC
  Hepatic: Normal liver function
  Renal: Normal renal function
  Other:
  -  Normal thyroid function
  -  Normal adrenal function
  -  Normal gonadal status
  -  No myeloma or other malignancy
  -  No alcoholism, hypercortisolism or diabetes mellitus
  -  No gastrointestinal tract disease or disorder associated with malabsorption

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction

Summary: RATIONALE: The use of endoscopy to place metal stents in the duodenum is less invasive than surgery for treating cancer-related duodenal obstruction and may have fewer side effects and improve recovery.
  PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of metal stents in treating patients who have cancer-related obstruction of the duodenum.

Detailed description: OBJECTIVES:
  -  Determine the objective response and clinical outcome in patients with duodenal obstruction secondary to malignancy treated with enteral Wallstents.
  -  Evaluate the efficacy and safety of this treatment in these patients.
  -  Evaluate the quality of life of these patients after enteral Wallstent placement.
  OUTLINE: Patients undergo enteral Wallstent placement through an endoscope under fluoroscopic guidance into the duodenum.
  Quality of life is assessed at 48 hours and 6 months after procedure.
  Patients are followed at 48 hours, 30 days, 6 months, and then yearly thereafter until death.
  PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Endoscopically confirmed localized tumor as the cause of duodenal obstruction
  -  All primary tumor types are eligible
  -  No prior duodenal Wallstents
  -  Must have symptoms of gastrointestinal obstruction, including:
  -  Inability to move bowels, absence of flatus, nausea/vomiting, abdominal pain, or diarrhea
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-3
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Platelet count greater than 50,000/mm^3
  Hepatic:
  -  INR no greater than 1.5 times upper limit of normal
  Renal:
  -  Not specified
  Cardiovascular:
  -  No cardiac condition
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No significant active infection (e.g., pneumonia, peritonitis, or wound abscess) that would preclude endoscopy
  -  No other serious concurrent illness
  -  No uncontrolled metabolic disease (e.g., diabetes mellitus or hypothyroidism)
  -  No dementia, psychiatric disorder, or altered mental status that would preclude compliance
  -  History of other neoplastic disease allowed
  -  Veterans Administration patients are not eligible
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Prior or concurrent chemotherapy allowed
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Prior or concurrent radiotherapy allowed
  Surgery:
  -  At least 3 weeks since prior surgery and recovered

Relevance to patient case: not relevant