araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: A Study to Explore Clinical Characteristics and Prognoses of N2 Patients With Non-small Cell Lung Cancer

Summary: A study to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases

Detailed description: A multi-centre real-world non-interventional observational study to retrospectively collect the study data on patient demographic/tumor biological characteristics and clinical treatments to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases.

Eligibility: Inclusion Criteria:
  -  Patients with surgeries from 2014 to 2017;
  -  Pathologically diagnosed patients with non-small cell lung cancer;
  -  Age > 18 years old;
  -  Patients with chest surgeries before hospitalization;
  -  Patients with N2 lymph nodes (+) after surgeries who received lymphadenectomy (Group 10 and 11 lymph nodes);
  Exclusion Criteria:
  - Patients with radiotherapies, chemotherapies and biological therapies for tumors

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: A Study to Explore Prognoses of the Patients With N2 Non-small Cell Lung Cancer

Summary: The trial was designed to compare the effectiveness of radical resections of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies in the patients with N2 non-small cell lung cancer

Detailed description: The trial is a multi-centre real-world non-interventional observational study. The Chinese patients with N2 non-small cell lung cancer enrolled from 2014 to 2017 who received radical resections of lung cancer and adjuvant chemotherapies will be included in the study and the study data on patient demographic/tumor biological characteristics and clinical treatment will be collected to evaluate compare effectiveness of radical resection of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies after surgeries.

Eligibility: Inclusion Criteria:
  -  Patients with radical resection of lung cancer enrolled from 2014 to 2019;
  -  Pathologically diagnosed patients with non-small cell lung cancer;
  -  Patients with age > 18 years old;
  -  Patients who did not receive chest surgeries before hospitalization;
  -  Patients with N2 lymph nodes (+) after surgeries;
  -  Patients who received lymphadenectomy for one group or more groups of lymph nodes;
  Exclusion Criteria:
  -  Patients with second primary tumors or multiple primary tumors;

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: A Phase 1, Study Evaluating the Safety, Tolerability, PK, and Efficacy of AMG 510 in Subjects With Solid Tumors With a Specific KRAS Mutation.

Summary: Evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant solid tumors.
  Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, recommended phase 2 dose [RP2D]) within investigated subject population groups.


Eligibility: Inclusion Criteria:
  -  Men or women greater than or equal to 18 years old.
  -  Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12Cmutation identified through DNA sequencing.
  -  Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
  Exclusion Criteria:
  -  Active brain metastases from non-brain tumors.
  -- History or presence of hematological malignancies unless curatively treated with no evidence of disease
  -  Myocardial infarction within 6 months of study day 1.
  -  Symptomatic congestive heart failure (New York Heart Association greater than class II)
  -  Unstable angina
  -  Cardiac arrhythmia requiring medication
  -  Gastrointestinal (GI) tract disease causing the inability to take oral medication.
  -  Active infection requiring intravenous (IV) antibiotics within 1 weeks of study enrollment (day 1)
  -  Positive Hepatitis B Surface Antigen (HepBsAg) or positive Hepatitis total core antibody with negative HepBsAg
  -  Detectable Hepatitis C virus
  -  Known positive test for HIV
  -  Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of alopecia (Grade 2 or 3 toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for greater than 6 months] may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor)

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Analysis of Survival Status of KRAS Mutation Advanced Non-small Cell Lung Cancer

Summary: this study is to analyze the survival condition of different groups about non-small cell lung cancer patients with KRAS mutations。The groups are made according to the treatment regime,brain metastases and gene mutation


Eligibility: Inclusion Criteria:
  -  advanced non-small cell lung cancer stage IIIB/IV
  -  KRAS mutation
  -  non-squmous
  Exclusion Criteria:
  -  squmous non-small cell lung cancer

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

Summary: The purpose of this study is to determine whether nivolumab plus ipilimumab or nivolumab alone is effective and safe in the treatment of solid tumors with High Tumor Mutational Burden (TMB-H)


Eligibility: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Participants with a refractory, metastatic, or unresectable histologically or cytologically confirmed solid malignant tumor with TMB-H who are refractory to standard local therapies, or for which no standard treatment is available.
  -  Available tumor tissue and blood for TMB testing
  -  Participants must have measurable disease for response assessment
  Exclusion Criteria:
  -  Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) or hematological malignancy as primary site of disease
  -  Participants who received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  -  Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment
  Other protocol defined inclusion/exclusion criteria could apply

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI

Summary: The survey is a retrospective study to evaluate the prognotic value of EGFR expression, KRAS mutations and tumor sideness in patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.

Detailed description: Primary objective:
  Progression-free survival
  Secondary objecive:
  Overall survival, best objective response, disease control rate and adverse events
  Number of Subjects: 41 patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.
  Plan of the Study:
  1. This is a retrospective study.
  2. Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 5 years.
  3. Duration of Treatment: Treatment was administered until disease progressed.

Eligibility: Inclusion Criteria:
  -  Age between 20-85 years old
  -  Histologically proven metastatic colorectal cancer (mCRC).
  -  Patients with progressing mCRC who were previously treated with FOLFOX, FOLFIRI, anti-VGFR monoclonal antibody (MoAb), and anti-EGFR MoAb if KRAS-wild-type tumors were identified.
  -  Patient was able to understand the requirements of the study and written informed consent was obtained from each subject.
  Exclusion Criteria:
  -  Patients who do not meet the including criteria or unwilling to participate

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: MRTX849 in Patients With Cancer Having a KRAS G12C Mutation

Summary: Evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in patients with advanced solid tumors that have a KRAS G12C mutation.

Detailed description: Evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally-available small molecule inhibitor of KRAS G12C.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
  -  Unresectable or metastatic disease
  -  Standard treatment is not available or patient declines
  -  Adequate organ function
  Exclusion Criteria:
  -  Active brain metastases
  -  History of intestinal disease or major gastric surgery or inability to swallow oral medications
  -  Other active cancer

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Cell Free DNA for the Diagnosis and Treatment in Early NSCLC

Summary: The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA (cfDNA) can aid screening of recurrence after complete resection of early stage non-small cell lung cancer.

Detailed description: During evolution of primary tumor, tumor cells can be released into the bloodstream. It has also been shown that circulating cell-free tumor DNA (cfDNA) is released from apoptotic or necrotic tumor cells. In a study of cfDNA level after surgery in colon cancer patients, they suggested that cfDNA could detect recurrence of cancer several months earlier than the conventional follow up studies. Following several reports have suggested that cfDNA can invade host cells and alter host cell biology to cause cancer metastasis.
  In this regard, we will collect from non-small cell lung cancer patients cohort who underwent curative resection, and will evaluate whether peripheral cfDNA can aid early detection of cancer recurrence. We will also study the genomic signature of cfDNA to assess the relationship between cfDNA and clinical outcome of non-small cell lung cancer patients.

Eligibility: Inclusion Criteria:
  -  All subjects need to sign the informed consent form
  -  All subjects have Non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively.
  -  Non-small cell lung cancer have to confirmed pathologically after operation
  -  Clinical stage I - IIIA by AJCC 7th staging system
  Exclusion Criteria:
  -  Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer
  -  Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix with 3 years before enrollment
  -  Recurrent lung cancer
  -  Stage IIIB, IV by AJCC 7th staging system

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: K-RAS and EGFR in Lung Cancer

Summary: Retrospective analysis where patients with histologically confirmed Non-small cell lung cancer (NSCLC) were centrally evaluated for the presence of KRAS and EGFR mutations.

Detailed description: A retrospective analysis, performed by the Hellenic Co-operative Oncology Group (HeCOG), in samples from patients with histologically confirmed NSCLC, who had been treated within HeCOG-affiliated centres from March 2000 through December 2012, were centrally evaluated for the presence of KRAS and EGFR mutations. All patients had available clinicopathological data at diagnosis. Formalin-fixed, paraffin-embedded tissue blocks were retrospectively retrieved from the HeCOG tumor repository. Cytologic material was prospectively submitted for genotyping in more recent years (2010-2012).

Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed NSCLC
  -  Signed and dated written informed consent
  -  Age 18 years
  -  Available cytological material
  Exclusion Criteria: -

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: INST 1204: PIK3CA Mutations as Biomarkers for Metastasis in Colon Cancer

Summary: This proposal seeks to further understand the contribution of the PIK3CA mutations in colon cancer, by correlating the type of hotspot mutation with the development of metastases in stage II and stage Ill patients.
  In order to do this, DNA will be extracted from either frozen or paraffin embedded colon cancer tissues to sequence PIK3CA, KRAS and BRAF. Clinical outcome data will be gathered to include metastases and survival to correlate with PIK3CA, KRAS and BRAF mutational status. Patients with stage II and stage Ill colon cancers will be identified in the University of New Mexico Human Tissue Repository and the NIH PLCO prevention trial biorepository.
  Existing banked tissues of stage II and Ill colon cancers will be collected. There will be no direct contact with living individuals. Epidemiological factors such as age, race, gender and outcome data of metastases and survival will be collected.

Detailed description: This proposal aims to identify PIK3CA mutations as a biomarker for metastasis.
  In order to do this, DNA will be extracted from either frozen or paraffin embedded colon cancer tissues to sequence PIK3CA, KRAS and BRAF. Clinical outcome data will be gathered to include metastases and survival to correlate with PIK3CA, KRAS and BRAF mutational status. Patients with stage II and stage Ill colon cancers will be identified in the University of New Mexico Human Tissue Repository and the NIH PLCO prevention trial biorepository.
  Existing banked tissues of stage II and Ill colon cancers will be collected. There will be no direct contact with living individuals. Epidemiological factors such as age, race, gender and outcome data of metastases and survival will be collected.
  Specific Aims:
  1. To develop and standardize methods for high throughput DNA extraction and analysis from colon tumors of patients with stage II and stage III disease harboring PIK3CA exon 9 and exon 20 mutations.
  2. To determine the correlation between wild type and PIK3CA, PIK3CA exon 9 and PIK3CA exon 20 mutations and development of metastatic disease and overall survival in stage II and stage III patients with colorectal cancer.

Eligibility: Inclusion Criteria:
  -  Specimen from patients with stage II and stage III colon cancer.
  Exclusion Criteria:
  -  Any other stage or type of disease outside of stage II and stage III colon cancer.

Relevance to patient case: not relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing

Summary: To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently.

Detailed description: -  Patients will have a blood sample drawn that will be analyzed for altered BRCA1 or BRCA2 genes. An alteration of BRCA1 or BRCA2 gene means there is an increased risk of developing breast and ovarian cancer.
  -  Patients participating in this study have either: 1) expressed an interest in testing for an underlying genetic factor that may account for the breast or ovarian cancer in their family; 2) have at least one relative that has been found to have a BRCA1 or BRCA2 alteration; 3) have a personal or family history of breast or ovarian cancer that is suggestive of a BRCA1 and BRCA2 alteration; or 4) has breast or ovarian cancer, or has at least one close relative with a history of breast or ovarian cancer and are a member of an ethnic group with increased frequency of BRCA1 and BRCA2 alterations.
  -  Patients will be randomized into one of two counseling groups. Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
  -  Throughout this study patients will be asked to complete questionnaires and psychological measures. These forms will be completed before and after the first visit, and a subset of them again at 2-4 weeks after the second visit, and at 4, 6, and 12 months.
  -  In addition 30 women will be asked to complete a 20-30 minute telephone interview with the program psychologist.

Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  Member of a family in which a BRCA1 or BRCA2 deleterious germline mutation has been identified, whether or not the individual has had cancer herself; written documentation of the family mutation must be available for laboratory purposes during the testing process.
  -  Personal and/or family history of breast/ovarian/other cancer consistent with BRCA 1/2 heredity with posterior probability of carrying an altered gene
  -  Documentation of key family member cancer diagnoses is required
  Exclusion Criteria:
  -  Males, will be offered BRCA 1/2 testing through other protocols
  -  Individuals unable to speak or write English
  -  Already participated in a genetic counseling program for BRCA1 or BRCA2 testing
  -  Life expectancy of less than 12 months.

Relevance to patient case: definitely relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Ovarian Screening Study

Summary: The objectives of this study are:
  -  To identify women at increased risk for developing ovarian cancer
  -  To detect ovarian cancers at an early stage
  -  To investigate the role of tumor membrane fragments as tumor markers for early ovarian carcinoma

Detailed description: In the year 2001 approximately 23,400 women in the USA are expected to be diagnosed with ovarian carcinoma and 13,900 will die of the disease. This means that within the USA more women die annually from ovarian cancer than all other gynecologic malignancies combined. Within the Commonwealth of Kentucky approximately 250 women per year develop ovarian carcinoma.
  Survival for patients with ovarian cancer is directly related to the stage of disease at diagnosis. Unfortunately, the majority of women present with advanced disease (Stage III and IV) and most of these patients will die of the disease.
  The aim of screening for ovarian cancer is to reduce the morbidity and mortality by detecting the disease at an early stage since ovarian cancer detected when disease is confined to the ovary (Stage I) is associated with a dramatically improved 5-year survival. Disease confined to the ovary may be cured in over 90% of patients, in some cases without the need for chemotherapy.

Eligibility: Inclusion Criteria:
  -  Asymptomatic women over the age of 45 with one or both ovaries.
  -  Women over the age of 25 with one or both ovaries and any of the following:
  -  A personal history of breast, colon or endometrial cancer or breast cancer gene (BRCA) 1 or 2 positive
  -  First-degree relative (mother, sister, daughter) with ovarian or breast cancer
  -  Two family members with either breast and/or ovarian cancer
  -  Mother, sister, daughter, grandparent with a positive BRCA1 or BRCA2 genetic test result.
  -  Past use of fertility drugs such as Clomid or Pergonal for more than a year.
  Exclusion Criteria:
  -  Women who are symptomatic of ovarian cancer

Relevance to patient case: definitely relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Identification of Novel Genetic Factors That Contribute to Risk for Breast Cancer

Summary: The purpose of this study is to identify novel genetic factors which distinguish breast cancer in younger women compared to older women. By identifying these novel genetic factors we believe more specific therapies can be developed and breast cancer may be prevented among women with an increased cancer risk. A woman does not have to live in St. Louis to participate.

Detailed description: Breast cancer takes its greatest toll on younger women, as it is the leading category of cancer deaths for women 20-39 years of age. Sadly, survival rates are lowest among women diagnosed at a young age. This impact is most significant among African-American women who have the highest incidence and mortality rate among women less than 45 years of age. The goal of our program is to identify the genetic factors which distinguish breast cancer in younger women compared to older women.
  Women who were diagnosed with invasive breast cancer 40 years of age or younger are invited to participate. The age at diagnosis is used to determine eligibility, not a woman's current age. Women who have undergone genetic testing of the BRCA1, BRCA2, p53, pTEN, e-cadherin, or LKB1 genes are eligible to participate. Young women with breast cancer are asked to: sign a consent form, submit a sample of blood, release their cancer related records, and answer some family history questions.
  We will use a family based case control approach in our analysis. As such, if a woman's parents are living, they will be invited to participate as a "comparison" group. The parents are asked to: sign a consent form, submit a sample of blood, and release any cancer records.
  A woman does not have to live in St. Louis to participate. All study related materials can be mailed directly to the young woman or her parents. There is no expense to the family. All materials are kept strictly confidential and participation is completely voluntary.

Eligibility: Inclusion Criteria:
  -  Women diagnosed with invasive breast cancer 40 years of age or younger. If their parents are living, the parents are also invited to participate, regardless of their history of cancer.
  Exclusion Criteria:
  -  Women diagnosed with in-situ breast cancer.

Relevance to patient case: not relevant