araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer

Summary: This is a phase 2 study (the second phase in testing a new drug or drug combination) to see how useful the combination of two drugs, panitumumab and trametinib, are in patients with advanced colorectal cancer with KRAS, NRAS, or BRAF wild type (genes that are not mutated).
  Panitumumab is a drug that is approved by Health Canada for the treatment of advanced colorectal cancer with KRAS wild type. Panitumumab works by binding to and blocking the protein, epidermal growth factor receptor (EGFR) from working.
  Trametinib is a drug that is approved by Health Canada for the treatment of melanoma with a mutation in the BRAF gene. Trametinib works by binding to and blocking mitogen-activated protein kinase kinase (MEK) 1 and MEK2 from working.
  Previous studies have shown that the combination of panitumumab and trametinib may be more useful in KRAS, NRAS, or BRAF wild type colorectal cancer.


Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  KRAS/NRAS/BRAF wild type colorectal cancer, not responsive to standard therapies, no approved or curative therapy, refuse standard therapy
  -  Prior 5-FU, oxaliplatin and irinotecan
  -  ECOG Performance Status of 0 or 1
  -  Able to swallow/retain oral drugs
  -  Able and agree to have provide tumor tissue/have biopsies
  -  Agree to use contraception
  -  Not pregnant
  -  Adequate organ system function
  Exclusion Criteria:
  -  Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapies <28 days or 5 half lives
  -  Prior EGFR, MEK, or RAF inhibitor or regorafenib
  -  Current use of prohibited medications
  -  Unresolved side effects
  -  GI disease or other condition affecting GI absorption
  -  Mucosal or internal bleeding
  -  Any major surgery <four weeks
  -  HIV, HBV, or HCV positive
  -  Active infection
  -  Leptomeningeal disease
  -  Brain metastases
  -  Unacceptable QTcF interval
  -  Significant uncontrolled arrhythmias
  -  Acute coronary syndromes, myocardial infarction, coronary angioplasty, or stenting or bypass grafting < 6 mos.
  -  Class II, III, or IV heart failure
  -  Other clinically significant ECGs
  -  Intra - cardiac defibrillators
  -  Cardiac metastases
  -  Condition that may interfere with patient safety
  -  Hypersensitivity to study drugs
  -  Severe or uncontrolled systemic diseases
  -  Pregnant or lactating
  -  Retinal vein occlusion
  -  Interstitial lung disease or pneumonitis
  -  Active liver or biliary disease

Relevance to patient case: possibly relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Efficacy and Safety of Oxaliplatin Combined With Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Colon Cancer Patients

Summary: The study aims to identify the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with local advanced colorectal cancer.


Eligibility: Inclusion Criteria:
  1. Performance status (ECOG) 0~2
  2. Histologically confirmed colon cancer.
  3. No prior treatment
  4. CT-defined T4 or lymph node-positive colon cancer
  5. Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 8 g/dL Bilirubin level ≤ 1.0 x ULN
  6. AST and ALT < 1.5 x ULN
  7. Serum creatinine ≤ 1.0 x ULN
  8. Life expectancy of ≥ 3 months
  9. Signed written informed consent
  Exclusion Criteria:
  1. Final stage with cancer cachexia
  2. Allergy for capecitabine or oxaliplatin
  3. Any evidence of extrahepatic metastases and/or primary tumor recurrence
  4. Severe organ failures or diseases, including: clinically relevant coronary disease, cardiovascular disorder or myocardial infarction within 12 months before study entry, severe psychiatric illness, severe infection and DIC

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer

Summary: OncoVAX® is the first cancer vaccine that both prevents cancer recurrence and
  addresses the diversity of cancer cells. In this pivotal randomized, multicenter Phase
  IIIb study in patients with Stage II colon cancer, OncoVAX is designed to use a patient's
  own cancer cells to mobilize the body's immune system to prevent the return of colon
  cancer following surgery.

Detailed description: OncoVAX is an active specific immunotherapeutic (ASI) stimulating a patient's immune
  response to autologous (patient-specific) tumor cells. It is comprised of sterile, live but
  non-dividing tumor cells obtained following standard-of-care surgical tumor resection for
  Stage II colon cancer. Within 35 days following surgery, patients are immunized with
  OncoVAX to prevent disease recurrence, which is incurable and occurs in up to 35% of
  patients. Patients are given three vaccinations once per week for three weeks, followed
  by a booster vaccination after six months. A previously completed Phase III trial
  published in The Lancet showed that OncoVAX cut the risk of recurrence by 61% in
  patients with Stage II colon cancer. The primary endpoint is Disease-Free Survival:
  defined as the time from curative surgery to the objective test confirming tumor
  recurrence or death due to any cause. The secondary endpoints are Overall Survival
  and Recurrence-Free-Interval. An interim analysis will be performed at a significance
  level of 0.005 once 2/3 of anticipated events have occurred, resulting in a significance
  level of 0.0483 at the end of the study. A total of 550 patients is planned, randomized
  1:1 to receive OncoVAX® plus surgery (n=275) or surgery alone (n=275).

Eligibility: Inclusion Criteria:
  -  Patients must have Stage II (IIA = T3N0M0, IIB = T4aN0M0, IIC = T4bN0M0) disease.
  -  Patients must have undergone curative resection and have no evidence of residual or metastatic disease.
  -  Following curative resection patients must have a CEA within normal limits. If elevated prior to resection, it must return to normal within 21 days post surgery and prior to randomization.
  Exclusion Criteria:
  -  Patients with prior radiation therapy or chemotherapy or a prior malignancy of any type will be excluded. However, subjects with prior, curatively-treated squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix will be eligible for participation in this study.
  -  Patients with more than one malignant primary colon cancer will be excluded.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: RhGM-CSF as Adjuvant Immunotherapy in Treating Stage III Colon Cancer

Summary: This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers.

Detailed description: This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers. Patients were randomly assigned to rhGM-CSF group or placebo group and treated with rhGM-CSF or placebo perioperation and during the adjuvant chemotherapy. The purpose of the study is to evaluate the antitumor immune effect of rhGM-CSF before surgery and adjuvant chemotherapy through DFS of 5 years and to observe the safety during the treatment in order to provide evidence for improvement in treating resectable colon cancer patients.

Eligibility: Inclusion Criteria:
  1. Diagnosed as resectable stage III colon cancer
  2. 18-70 years old
  3. ECOG performance status ≤2
  4. Unexposed to rhGM-CSF in 6 months
  5. Signed an informed consent document
  Exclusion Criteria:
  1. Secondary primary cancer, or concurrent primary malignancies (except for basal cell or squamous cell skin cancer, cervical cancer in situ, and other cancer with disease free for more than 5 years)
  2. Complete intestinal obstruction
  3. Events within 6 months before randomization: myocardial infarction, sever or unstable angina, coronary artery or peripheral arterial bypass surgery, congestive heart failure ( NYHA functional class of III or IV ), stroke and any myocardial dysfunction in a transient ischaemic attack
  4. Abnormal liver and kidney function (Serum creatinine > 1.5 x ULN, total bilirubin > 1.5 x ULN, transaminase > 3 x ULN ), abnormal pulmonary function (FEV1<60% or diffusing capacity of the lung for carbon monoxide < 55% )
  5. Bone marrow dysfunction ( Hb<9.0 g/dL、ANC<1.5 x 109/L、PLT<100 x 109/L )
  6. ITP or immunodeficiency
  7. Uncontrolled infection, including HBV, HCV, HIV infection
  8. Female patients who has been pregnant or planning to, and those during lactation
  9. Known allergic to E.coli agents or rhGM-CSF or any severe allergic history to other drugs
  10. Other cases that the researcher found ineligible

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers

Summary: The primary objective of this study is to obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract.

Detailed description: This is a multi-site, prospective sample collection study. Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.
  One stool sample from approximately 300 subjects will be collected in this study. A blood sample will also be collected from subjects.

Eligibility: Inclusion Criteria:
  -  Subject is male or female, 40-90 years of age, inclusive.
  -  Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or colorectal polyp/adenoma/mass that is equal or larger than 1 cm in pre-enrollment colonoscopy with residual lesion in the colon of sufficient size to require additional surgical excision or complex colonoscopic polypectomy.
  -  Subject understands the study procedures and is able to provided informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
  Exclusion Criteria:
  -  Subject has actively bleeding hemorrhoids (blood on toilet paper or bright red blood clots in the toilet bowel during bowel movement).
  -  Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Synergistic Anti-tumor Effect of ChangTai Keli for Colon Cancer Patients

Summary: The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based on chemotherapy for colon cancer patients by a randomized, parallel-group, double-blind, multicenter clinical study.

Detailed description: Although many therapies exist and are being developed to relieve symptoms for colon cancer, there are few randomized controlled clinical trials to evaluate comprehensive Traditional Chinese medicine (TCM) interventions in colon cancer. The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based on chemotherapy for colon cancer patients. This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the synergistic anti-tumor effect of TCM on colon cancer patients. Following a run-in period, approximately 360 subjects will be randomly assigned to conventional chemotherapy treatment group, ChangTai Keli and conventional chemotherapy treatment group for 26 weeks. After the 26 weeks treatment period, subjects in two treatments arms will follow-up 36 months.

Eligibility: Inclusion Criteria:
  1. collaboration from hospital oncology patients in hospital. Confirmed by pathology or cytology for colon cancer, Ⅱ A - Ⅳ period of patients with colon cancer line (or late postoperative palliative chemotherapy).
  2. age > 18 years of age, and the 75 - year - old patient or less;
  3. fitness score (ECOG PS) 2 minutes or less, expected lifetime > 6 months;
  4. volunteered for the clinical research, and sign the informed consent.
  Exclusion Criteria:
  1. patients with other primary malignant tumors within 1 year;
  2. intentional, severe liver and kidney disease patients with serious obstacle and function;
  3. pregnancy or lactation women, mental disorders to cooperate to complete the healer;
  4. is in other subjects or attended other drugs test interval < 3 months.
  5. do not meet the inclusion criteria;

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: QoLiCOL - Quality of Life in Colon Cancer

Summary: All patients presenting at participating hospitals during the recruitment period with a newly diagnosed colon cancer, regardless of stage and planned treatment, will be eligible for inclusion. They will answer a questionnaire on health related quality of life, physical symptoms, functional impairments and socioeconomic status at diagnosis and after 12, 36 months. Clinical data including recurrence, survival, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the Swedish ColoRectal Cancer Registry (SCRCR)

Detailed description: QoLiCOL is an explorative, prospective, longitudinal, non-interventional, international, multicenter study of health-related quality of life, physical symptoms, functional impairments and socioeconomic burden in colon cancer patients. All patients presenting at participating hospitals during the recruitment period with a newly diagnosed rectal cancer, regardless of stage and planned treatment, will be eligible for inclusion. Patients will be followed for 3 years. They will be asked to answer questionnaires at three different time points during follow-up: at diagnosis and after 12 and 36 months. Clinical data, including recurrence, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the national quality registry for rectal cancer in Denmark and Sweden. As these registries differ in some areas between the countries, additional data will be collected through short CRF:s.

Eligibility: Inclusion Criteria:
  -  Colon cancer newly diagnosed.
  -  Planned treatment presented
  Exclusion Criteria:
  -  No Colon cancer diagnosis,
  -  below 18 years of age,
  -  no informed consent or withdrawn informed consent.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma

Summary: Immunohistochemical detection of the BRAF-V600E mutation on pre-operative fine needle aspiration biopsy (FNAB) from patients suspected for papillary thyroid carcinoma, using the mutation specific antibody VE1.

Detailed description: The BRAF mutation is reported to be present in approximately 50% of papillary thyroid carcinomas (PTC). The mutation has been associated with poor prognosis and more advanced disease stage. Therefore, pre-operative detection of the BRAF-V600E mutation may be of clinical interest in order to individualize treatment of patients with BRAF positive PTC.
  FNABs are performed immediately before the thyroid operation, and BRAF-V600E detection using VE1 is performed on clots. The VE1 stain is compared to the mutation status of the removed cancer or control tissue using the Cobas test.

Eligibility: Inclusion Criteria:
  -  Bethesda system of reporting thyroid cytology (BSRTC) group 5-6 on pre-operative FNAB from the nodule (>1cm)
  -  Undergoing thyroid surgery (histology of index nodule)
  Exclusion Criteria:
  -  Not undergoing thyroid surgery

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Colon Cancer

Summary: Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence.
  The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.

Detailed description: The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order.
  1. immediate before anesthesia induction
  2. postoperative 1 hours
  3. postoperative 24 hours
  Serum in blood will be obtained and activity of helper T cell, natural killer cell and level of serum cytokine will be evaluated by flow cytometry or enzyme-linked immunosorbent assay

Eligibility: Inclusion Criteria:
  -  patient who was planned to undergo colon cancer surgery.
  Exclusion Criteria:
  -  age < 20 years old
  -  history of hypersensitivity reaction in propofol or sevoflurane
  -  history of previous cancer
  -  patient with ongoing inflammation

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients

Summary: This is a phase 1b/2a study investigating the safety and effect of Sym004 in combination with FOLFIRI (chemotherapy) when administered every second week.
  The phase 1b (dose-escalation) portion of the trial is expected to begin Q1 2016. Patients will be sequentially enrolled to dose-escalation cohorts until establishment of the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Sym004 in combination with FOLFIRI.
  The phase 2a (dose-expansion) portion of the trial is expected to begin after establishing the RP2D.


Eligibility: Main inclusion Criteria:
  1. Male or female, at least 18 years of age at the time of informed consent
  2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  3. Histologically or cytologically confirmed, locally advanced or metastatic colorectal cancer (CRC) that is documented to be without Kirsten rat sarcoma (KRAS) or Neuroblastoma rat sarcoma (NRAS) gene mutations (i.e. tumors must express the KRAS and NRAS wild type (WT), exon 2, 3 and 4).
  4. Failed* treatment for locally advanced or metastatic disease with first-line combination therapy of oxaliplatin and a fluoropyrimidine, with or without bevacizumab, during treatment or < 3 months after the last dose of first-line therapy and within < 3 months of C1/D1.
  Patients who discontinued first-line therapy due to toxicity may be enrolled provided progression occurred < 6 months after the last dose of the first-line therapy regimen.
  or Failed* adjuvant therapy with combination therapy of oxaliplatin and a fluoropyrimidine during treatment or within < 6 months after the last dose of oxaliplatin and within < 6 months of C1/D1.
  -  Failure is defined as radiologic progression
  5. Eligible for FOLFIRI
  6. Measurable disease according to RECIST v1.1
  Main exclusion Criteria:
  1. Prior therapy with anti-EGFR antibodies, anti-EGFR small molecule inhibitors or irinotecan (CPT-11)
  2. Any antineoplastic agent (standard or investigational) within 4 weeks prior to C1/D1
  3. Significant gastrointestinal abnormalities
  4. Patients with a significant cardiovascular disease or condition
  5. Abnormal hematologic, renal or hepatic function

Relevance to patient case: possibly relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Molecular Stethoscope

Summary: The study aims to provide a more complete characterization and understanding of the genetic causes of and tumor DNA detection potential in colorectal cancer. Ultimately findings of this study will be used to develop early detection tests for colorectal cancer that are minimally invasive (based on a blood test). It is hoped that reliable, minimally invasive, early detection methods will lead to improved screening rates, increased screening safety, longer colorectal cancer survival, and overall cost savings.
  In order to assess the test's ability to detect tumor DNA, 25 participants with known colorectal cancer who will be undergoing surgical resection of the colon as part of their clinical care will be recruited. The investigators will collect blood from participants prior to surgery, tumor and normal tissue removed during surgery, a series of blood samples after surgery for up to one year and relevant medical records. DNA variants identified in blood will be compared against tissue samples. Serial samples will be analyzed to assess the variance in amount of circulating tumor DNA across time with standard treatment.


Eligibility: Inclusion Criteria:
  -  Colorectal cancer sent for surgical colonic resection (all stages) OR
  -  High risk adenoma sent for surgical colonic resection
  Exclusion Criteria:
  -  Chemotherapy before surgical treatment
  -  Invasive procedure resulting in damage to tissue (e.g., surgery, biopsy, thermal ablation) in the 7 days prior to baseline (pre-surgical) blood collection
  -  Radiation therapy before surgical treatment
  -  Bone marrow transplant

Relevance to patient case: not relevant