araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Laparoscopic Surgery for T4 Tumor of the Colon Cancer (LST4C Trial)

Summary: The purpose of this study is to compare the short- and long-term survival of laparoscopic surgery and conventional open surgery for T4 colon cancer

Detailed description: The investigators previous study indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy can be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. However, the clinical value of laparoscopic surgery for T4 colon cancer was only validated in some retrospective study and some prospective study in single institute with small sample of patients. The aim of the present study is to compare the short-and long-term survival outcomes of laparoscopic surgery and conventional open surgery for T4 colon cancer as well as the mortality and the morbidity. The number of patients needed to get a 80% power is 1960. The average number of patients/surgical center is approximately 200 in each of 10 surgical centers. The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center. The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed equestionnaire.
  Systematically analyze and compare the disease free survival rate, the mortality, the morbidity, and the proportion of completion of laparoscopic surgery of the two surgical strategies (laparoscopy VS conventional open surgery).

Eligibility: Inclusion Criteria:
  -  Able to provide written informed consent
  -  Histologically confirmed diagnosis of colon carcinoma
  -  CT or MRI verified as T4 colon cancer without involvement of other organs
  -  Without multiple lesion other than carcinoma in situ
  -  Tumor size < 8 cm
  -  No bowel obstruction
  -  Sufficient organ function
  -  No history of gastrointestinal surgery
  -  18 years of age or older
  -  Performance Status (ECOG) 0, 1 or 2 and life expectancy > 12 weeks
  -  Operable patients
  Exclusion Criteria:
  -  • Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding
  -  Unstable or uncompensated respiratory or cardiac disease
  -  Serious active infections
  -  Hypersensitivity to capecitabine/fluorouracil or oxaliplatin
  -  Stomatitis, ulceration in the mouth or gastrointestinal tract
  -  Severe diarrhea
  -  Peripheral sensory neuropathy with functional impairment

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Role of Senescence in the Development of Endometrial Cancer

Summary: Several molecular studies showed chromosomal alterations in patients with endometrial cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of interest have been identified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...).
  A study has already been carried out at the Reims University Hospital with inclusion of patients with endometrial cancer and patients with endometrial hyperplasia. It identified specific alterations of nosologic continuum of pathology and characterize areas of interest on the genome.

Detailed description: make a pangenomic investigation of genetic abnormalities in atypical endometrial hyperplasia and endometrial cancers.

Eligibility: Inclusion Criteria:
  -  patient with endometrial hyperplasia or endometrial cancer
  -  patient consenting to participate to the study
  -  patient enrolled in the national healthcare insurance program
  -  patient older than 18 years
  Exclusion Criteria:
  - patient with neoadjuvant chemotherapy or radiotherapy prior to surgery

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: ASPIRIN Trial Belgium

Summary: The purpose of this study is to determine whether acetylsalicylic acidis effective on the recurrence and survival of colon cancer patients.
  Condition or disease: Colon Cancer (Adjuvant Therapy) Intervention: Drug: Acetylsalicylic acid; Drug: Placebo Acetylsalicylic acid Phase 3

Detailed description: The purpose of this study is to determine the effect of 80mg acetylsalicylic acid (given orally once daily for 5 years) on 5 year overall survival (OS) for stage II and III colon cancer patients of 45 years of age and older. Preclinical, epidemiologic and clinical evidence suggest that acetylsalicylic acid use may reduce overall cancer risk and mortality in colon cancer patients. It is a phase III double blind placebo controlled, randomized trial of adjuvant low-dose acetylsalicylic acid in colon cancer patients. Patients will be stratified at randomization by centre, age (<70 and ≥70 years) chemotherapy use (any versus none) and disease stage.

Eligibility: Inclusion Criteria:
  -  Age ≥45 years
  -  Patients must have TNM stage that is one of the following: pT3-4; N0-2 and M0, or pT1-2 and N1-2 (UICC stage II and III) (in case of >1 tumour: largest tumour is stage II or III)
  -  Patients must have completed surgical resection (R0) (both laparoscopic and open surgery) within 12 weeks of randomisation
  Exclusion Criteria:
  -  Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)
  -  Patients currently taking oral anti-coagulants or use of LMWH
  -  Patients currently taking acetylsalicylic acid for any reason
  -  Patients with a history of bleeding disorders or active gastric or duodenal ulcers
  -  Patients currently taking high dose systemic glucocorticoids.(≥ 30 mg predniso(lo)n)
  -  Patients with (suspected) (non-) polyposis syndrome (FAP/AFAP, MAP, Lynch syndrome)
  -  Patients with >100 polyps of the colon or a known hereditary syndrome of the colon in a first degree family member
  -  Allergy or intolerance to salicylates.
  -  Patients with a history of other malignancies in the last 5 years, except for SCC or CIN.
  -  Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Signaling Pathways Targeting Colorectal Cancer in Egypt

Summary: Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second leading cause of cancer-related death worldwide. In Egypt, CRC constitutes 4.2% of all cancers with median age is 50 years old.

Detailed description: The TP53-induced glycolysis and apoptosis regulator (TIGAR) is a transcriptional target of p53. TIGAR functions as a fructose-2,6-bisphosphatase, decreasing the flux through the main glycolytic pathway. Consequently, glucose metabolism diverted into the pentose phosphate pathway (PPP). This results in TIGAR-mediated increase in cellular NADPH production, which contributes to the scavenging of ROS by reduced glutathione and thus a lower sensitivity of cells to oxidative stress-associated apoptosis. PPP also produce ribose phosphate for DNA synthesis and repair that play a role in tumor development and cell survival in tumor microenvironment. A high expression level of TIGAR was observed in cancers such as breast cancer, hepatocellular carcinoma, intestinal cancer, and glioblastoma. These studies suggested that TIGAR may act as an oncogene that support cancer progression.
  The tripartite motif containing 59 (TRIM) proteins have been implicated in many biological processes including cell differentiation, apoptosis, transcriptional regulation, and signaling pathways.
  It is related to several cancers. The oncogenic effect of TRIM59 on tumor proliferation and migration has been studied in various cancers, including gastric cancer, osteosarcoma, lung and CRC. The biological activity of TRIM59 has been observed to be closely associated with the regulation of P53. TRIM59 interacts with P53, leading to P53 ubiquitination and degradation, and consequently promotes tumor growth and migration. TRIM59 functions as an oncogene in CRC progression. It also activates the PI3K/AKT pathway. Increased activity of this pathway is often associated with tumor progression and resistance to cancer therapies. AKT can control TIGAR protein translation by activation of mTOR.
  Targeting TRIM59 inhibition will inhibit PI3K-Akt pathway downregulate TIGAR protein translation. This is in turn downregulates GSH levels, increases ROS production, leading to cell death and blocks the cellular proliferation and survival of cancer cells leading to tumor regression. Therefore, TRIM59 protein can serve as a new potential therapeutic target for CRC.

Eligibility: Inclusion Criteria:
  -  All Patients confirmed histopathologically to have early stages of colorectal cancer.
  -  Risky group patients (including those with ulcerative colitis, chron's disease, familial adenomatous polyposis).
  Exclusion Criteria:
  -  Patients with previous history of CRC treated with chemotherapy or presence of other types of cancer.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Research on the Treatment of Metastatic Colon Cancer Patients Treated by FOLFOXIRI

Summary: Colon cancer with metastase in the diagnose time account for one significant rate and has a increasing trend. The treatment result of this patient group rests modest. The biological therapeutic treatment is still expensive for major part of Vietnamese patients. So that, research on a new affordable and efficacious chemotherapy combination for these patients is extremely necessary in our country The purpose of the study is to comment somes clinico-pathology features of metastatic colon cancer patients whose disease was not radically resectable.
  The second aim is to Evaluate the treatment result and toxicity of FOLFOXIRI in these patients

Detailed description: In the world, colorectal cancer is the third most common cancer in male and the second most common cancer in female. In VietNam, the disease is the fourth cancer in male, the sixth cancer in female and increasing recently. About 20-40% of the colon cancer patients had distant metastasis at the time of diagnose, those treatment outcome remains poor (5years survival is about 11%). The targetted therapy medications are still not affordable for majority of Vietnamese patients. So that, 3 cytotoxic drugs (5-Fluoro-Uracil, Oxaliplatin and Irinotecan) remain back-bone in the treatment of metastatic colon cancer.
  According to one meta-analysis, the overall survival rate significantly correlated to the use of all 3 these drugs in the treatment time. If patients were give two drugs as the doublet in a line (FOLFOX/XELOX, FOLFIRI/XELIRI), not 100% of patients are treated with all 3 these drugs because some abandonned the following treatment lines. So, the trials that give all 3 drugs in a line (first-line) as triplet (FOLFOXIRI) were carried out and had primirily good outcome. In 2010, FOLFOXIRI were recommended in NCCN guideline.
  In VietNam, FOLFOXIRI has been applied to treat patient since 2013. However, since then there was no clinical trial to evaluate the efficacy and the toxicity of this combination. Therefore, we carried out the work "Research on the treatment of metastatic colon cancer patients treated by FOLFOXIRI"

Eligibility: Inclusion Criteria:
  -  39 colon cancer patients with metastase at the diagnotic time, impossiblity of radical resection, adenocarcinoma, treated by at least 3 cylces of FOLFOXIRI in the first-line in the Oncology and Palliative Care Department, Ha Noi medical university hospital, from September 2013 to April 2017

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Collection of Blood, Urine, and Stool to Monitor MetastaticColorectal Cancers

Summary: This trial studies the monitoring of therapy and progression by collecting blood, urine, and stool from participants with colorectal cancer that has spread to other places in the body or cannot be removed by surgery. Studying samples of blood, urine, and stool from participants with colorectal cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. Detection of mutated Kras in urine specimen of patients with Kras mutated metastatic colon cancer on first, second, or third line therapy.
  II. Detection of new Kras in urine in patients without Kras mutated metastatic colon cancer on therapy which includes anti-EGFR antibodies (cetuximab or panitumumab).
  SECONDARY OBJECTIVES:
  I. Changes of the stool microbiome with chemotherapy and at progression of the disease.
  DESCRIPTIVE OBJECTIVES:
  I. Changes in the quantity of mutated Kras, Braf or PI3K in urine deoxyribonucleic acid (DNA) over the cycles of first line therapy.
  II. Associations between the quantity of mutated Kras, Braf or PI3K in urine DNA, molecular make up of circulating tumor cells (CTCs), cell free DNA and progression over the course of first line therapy.
  III. Feasibility of detection of exosome in the plasma of colorectal cancer patients on first line chemotherapy in Dr. Fabbri?s lab at Children?s Hospital Los Angeles.
  IV. Feasibility of detection of tumor DNA in the plasma of colorectal cancer patients on first line chemotherapy.
  OUTLINE:
  Participants undergo collection of blood and urine at baseline, on day 1 of courses 1, 2, and 3, at restaging, and at disease progression. Participants may undergo collection of stool at baseline, on day 1 of course 2, and at disease progression. Participants also undergo biopsy within 4 weeks of disease progression.

Eligibility: Inclusion Criteria:
  -  All patients with metastatic/unresectable colorectal cancer who will undergo first, second, or third line therapy; the participating investigator will select treatment, however, patients with Kras wild type must receive anti-EGFR therapy to be eligible for this study
  -  Subject consent to enrollment on the protocol
  -  Histologically confirmed metastatic or un-resectable colorectal cancer, known Kras status; knowledge of other mutations is optional
  -  Willingness to undergo biopsy at the time of progression
  -  Willingness to follow the study instructions for collection of specimens
  -  Available archival tissue

Relevance to patient case: definitely relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance

Summary: This study will test the hypothesis that the molecular changes present in ectopic endometriosis lesions correlate with progesterone-resistant disease (using the criteria defined in this study) and are present in matched eutopic endometrium.

Detailed description: Tissues from 100 patients with endometriosis will be analyzed with droplet digital PCR (ddPCR) targeted sequencing and responders (n=50) will be compared to non-responders (n=50) after controlling confounding factors.
  From a subset of the 100 cases, whole exome sequencing (WES) and Methylation-Specific PCR (MSP)-based methylation profiling on microdissected epithelium and stroma will be performed in matched eutopic and ectopic tissues from 20 patients with known cancer-associated mutations or 20 controls.

Eligibility: Inclusion Criteria:
  -  Signed informed consent.
  -  Gender: female.
  -  Age: 18-45 years at the time of signing consent.
  -  Clinical or surgical diagnosis of endometriosis undergoing laparoscopy.
  -  Controls may not have clinical or surgical diagnosis of endometriosis.
  -  Regular menstrual cycles.
  -  BMI between 18-40 kg/m2.
  -  Sexually active or have had a previous vaginal exam that used a speculum.
  -  English speaking
  Exclusion Criteria:
  -  Use of any kind of steroidal therapy including oral contraceptives, Norplant, estrogen replacement/supplemental therapy, androgens (Danazol, Cyclomen, Danocrine, testosterone) or progesterone. She may not be taking or be on Celebrex.
  -  Pregnant.
  -  Presence of pelvic infection.
  -  Mullerian anomalies with absence of a cervix.
  -  History of cancer of the reproductive tract.
  -  Presence of undiagnosed uterine bleeding.
  -  Treatment with intrauterine device (IUD) or progestin-containing intrauterine device.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer

Summary: To explore the effect of unfavorable histological features on the clinical outcomes of patients receiving radical resection of colon cancer.


Eligibility: Inclusion Criteria:
  1. Age: 18-80 years old;
  2. Postoperative pathology confirmed colon adenocarcinoma;
  3. The tumor is located from the cecum to the sigmoid colon;
  4. No distant organ metastasis;
  5. ASA score I-III.
  Exclusion Criteria:
  1. Simultaneous or metachronous multiple primary colorectal cancer;
  2. History of previous malignant tumors (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial skin cancer)
  3. local excision procedure;
  4. palliative resection (R2 resection);
  5. pregnant or lactating women.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?

Summary: This study is designed to examine the impact of telephone-based colorectal cancer risk assessment on colorectal screening attitudes and behavior among previously unscreened adults ages 50 to 75.

Detailed description: Colorectal cancer (CRC) remains the 3rd most common cancer in the US. Most CRCs are preventable, but screening participation remains suboptimal. Several factors have been associated with screening compliance, such as perception of CRC risk. Here we study the impact of telephone-based administration of the National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT) compared to usual care.

Eligibility: Inclusion Criteria:
  -  Patient of any participating physician
  -  Not having had any colorectal cancer screening test prior
  -  Able to speak English
  Exclusion Criteria:
  -  Personal history of inflammatory bowel disease
  -  Personal history of colorectal cancer
  -  Personal history of Lynch syndrome or Familial Adenomatous Polyposis
  -  Have already received colorectal cancer screening

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: TPST-1120 as Monotherapy and in Combination With (Nivolumab, Docetaxel or Cetuximab) in Subjects With Advanced Cancers

Summary: This is a phase 1/1b open label, multicenter dose escalation and dose expansion study to investigate the safety, tolerability and anti-tumor activity of TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha) as monotherapy and in combination with other systemic anticancer agents including nivolumab, an anti-PD1 antibody, docetaxel, a cytotoxic chemotherapeutic agent and cetuximab, an anti-EGFR antibody in subjects with advanced solid tumors.

Detailed description: This is a phase 1/1b open label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha) in adult subjects with selected advanced solid tumors. TPST will be administered as monotherapy and in combination with standard of care systemic anticancer agents including nivolumab, an anti-PD1 antibody, docetaxel, a cytotoxic chemotherapeutic agent and cetuximab, an anti-EGFR antibody in subjects with advanced solid tumors. This trial is composed of dose escalation and dose expansion cohorts.

Eligibility: Inclusion Criteria
  -  Eastern Cooperative Oncology Group performance status of 0-1 at enrollment
  -  Progressive disease or previously untreated tumors for which no standard therapy exists or treatment naïve at the time of study entry are eligible
  -  Have at least one measurable lesion according to RECIST v1.1
  -  Must be willing to consent and undergo tumor biopsies
  Exclusion Criteria
  -  Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, a specimen-collection study or the follow-up period of an interventional study
  -  Any chemotherapy, monoclonal antibody therapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment within 28 days of commencing TPST-1120 treatment. Targeted therapy such as tyrosine kinase inhibitors within 14 days of commencing first dose of study drug(s)
  -  Any unresolved immune related adverse event > Grade 1 with prior immunotherapy treatment
  -  Symptomatic, untreated or actively progressing central nervous system metastases
  -  Have received fibrates within 28 days before first dose of investigational agent

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

Summary: Expanded access for patients with cancer with RET activation who are ineligible for an ongoing LOXO-292 clinical trial or have other considerations that prevent access to LOXO-292 through an existing clinical trial.

Detailed description: N/A for expanded access

Eligibility: Inclusion Criteria:
  -  Diagnosis of cancer with RET activation, who are not eligible for an ongoing LOXO-292 clinical trial and are medically suitable for treatment with LOXO-292
  Exclusion Criteria:
  -  Currently enrolled in an ongoing clinical study of LOXO-292 or another RET inhibitor

Relevance to patient case: not relevant