araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Circulating Tumor DNA Detection in Surveillance of Surgical Lung Cancer Patients

Summary: Conduct a prospective study to confirm blood and urine ctDNA detection value in non-small-cell lung cancer patients.

Detailed description: Studies have shown the feasibility of detecting mutation status by blood and urine circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no prospective has been conducted for usage of ctDNA in postoperative surveillance of NSCLC patients.
  We plan to compare tumor makers and radiographic approaches with blood and urine ctDNA in surveillance to assess the lead time of postoperative tumor relapse in stage ⅢA NSCLC patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.

Eligibility: Inclusion Criteria:
  -  Aged 18 to 80 years
  -  Undergo radical surgery（R0 resection）
  -  Histologically confirmed diagnosis of stage ⅢA non-small cell lung cancer
  -  Positive Driver mutation(EGFR、PTEN、PIK3CA、BRAF、K-RAS、Her2) in tumor tissue
  -  Blood or urine circulating tumor detect the driver mutation detected in tumor tissue
  -  Patients must have given written informed consent
  Exclusion Criteria:
  -  Unable to comply with the study procedure
  -  Malignant tumor history within the past 5 years
  -  Patients who received any treatment prior to resection
  -  R1 or R2 resection
  -  Coexisting small cell lung cancer
  -  Received target drug therapy after surgery
  -  Unqualified blood or urine samples

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure

Summary: This is a study whose focus is on understanding the clinical utility of rectal ultrastructure in detecting colonic neoplasm. The method uses Low-coherence Enhanced Backscattering Spectroscopy (LEBS).

Detailed description: The investigators use an optic probe which is a small device that uses light to assess the colon tissue. This probe will be used to identify subjects who do and do not have precancerous changes in the colon by capturing the light reflected back from the rectal wall and that will be assessed without the need for colonoscopy and bowel preparation (i.e unprepped). This device may detect early cancerous changes in colon tissue with higher accuracy than current tests.

Eligibility: Inclusion Criteria:
  - Subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance
  Exclusion Criteria:
  -  age <50
  -  personal/family history of colonic neoplasia
  -  personal history of coagulopathy
  -  (retrospectively) failure to complete or inadequate colonoscopy
  -  any patients harboring non-pathoglocially normal rectum (i.e. presence of lesion, inflammation, polyp, adenomas at rectum)

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Detection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer

Summary: RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping is assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and BRAF genotyping results achieved in analyzing circulating plasma DNA using OncoBEAM™ technique with those achieved using the standard genotyping techniques and formalin-fixed paraffin embedded samples.

Detailed description: The study will be proposed to all patients with a metastatic colorectal cancer.
  Study information will be given to the patient during a routine medical examination. The patient will be included after checking inclusion criteria and signature of the informed consent form
  Blood sampling (30 ml) will be performed before the initiation of the first line metastatic chemotherapy.

Eligibility: Inclusion Criteria:
  -  Adult subjects with newly diagnosed, anti EGFR treatment naïve metastatic colorectal cancer
  -  Standard of Care RAS/RAF tests performed on FFPE tumor sample as part of routine
  -  Patient information and written informed consent form signed
  -  Patient must be affiliated to a social security system
  -  Age : 18 years and older
  Exclusion Criteria:
  -  Patient bearing non-metastatic colorectal cancer
  -  Patient with local relapse only
  -  Patient with exclusive nodal metastases
  -  Patient whose health contraindicates a 30 ml blood sample
  -  Blood transfusion within 1 week prior blood collection
  -  Patient having received any chemotherapy or / and radiotherapy within 15 days prior to blood collection
  -  History of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix
  -  Persons deprived of liberty or under supervision

Relevance to patient case: possibly relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Humanized CAR-T Therapy for Treatment of B Cell Malignancy

Summary: The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a humanized scFv. All participants will receive autologous chimeric antigen receptor engineered T cells.

Detailed description: CD19 has been extensively evaluated as a therapeutic target for recurrent or refractory B cell malignancy by chimeric antigen receptor T cell therapy, the single chain antibody sequence (scFv) against CD19 derived from a mouse hybridoma was widely employed. However, the immunogenicity of the mouse scFv sequence might be one of the reasons that CAR-T cells cannot persist in vivo for long. In present study investigators replace the mouse-derived scFv with a a humanized one and evaluate its safety and efficacy.

Eligibility: Inclusion Criteria:
  -  Age≥10 at the time of consent
  -  Survival time>12 weeks
  -  B cell hematological malignancies by pathological examination
  -  Chemotherapy failure or recurrent B cell malignancy
  -  Creatinine< 2.5mg/dl
  -  Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level
  -  Karnofsky Performance Status>50% at the time of screening
  -  Bilirubin<2.0mg/dl
  -  Adequate pulmonary, renal, hepatic, and cardiac function
  -  Fail in autologous or allogenic haemopoietic stem cell transplantation
  -  Free of leukocytes removal contraindications
  Exclusion Criteria:
  -  Pregnant or nursing women
  -  Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
  -  Previous treatment with any gene therapy product
  -  Abnormal vital signs
  -  Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
  -  General infection or local severe infection, or other infection that is not controlled
  -  Dysfunction in lung, heart, kidney and brain.
  -  Severe autoimmune diseases
  -  other symptoms that are not applicable for CAR-T

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations on Tumor DNA Circulating in Metastatic Colorectal Cancer

Summary: The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin


Eligibility: Inclusion Criteria:
  -  Patients with metastatic or locally advanced colorectal carcinoma with a KRAS, BRAF or NRAS mutation
  -  Age ≥ 18 years
  -  Patient information and written informed consent form signed
  -  Patient must be affiliated to a social security system
  Exclusion Criteria:
  -  Patients whose health-cons indicates a blood sample 10mL
  -  Age < 18 years
  -  Pregnant or breast feeding females
  -  Persons deprived of liberty or under supervision

Relevance to patient case: definitely relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Laparoscopic Surgery for T4 Tumor of the Colon Cancer

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 e-questionnaire.
  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: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer

Summary: The main purpose of this study is to evaluate the safety of the study drug prexasertib in combination with ralimetinib in participants with advanced or metastatic cancer.


Eligibility: Inclusion Criteria:
  -  Advanced or metastatic cancer.
  -  Able to swallow tablets.
  -  For Part B, you will need to have colon cancer or non-small cell lung (NSCLC) cancer with KRAS and/or BRAF mutations.
  -  Discontinued all previous treatments for cancer and recovered from the acute effects from the therapy.
  Exclusion Criteria:
  -  Active infection (fungal, viral, or bacterial).
  -  Active cancer in your brain or spinal cord.
  -  Acute or chronic leukemia.
  -  Serious heart condition.
  -  Disease that requires immunosuppressant therapy.
  -  Diagnosis of inflammatory bowel disease.
  -  Major small bowel resection that interferes with your body's ability to absorb the oral medicine.
  -  Participated in other clinical trials investigating prexasertib or ralimetinib.
  -  Pregnant or breastfeeding.
  -  Other pre-existing conditions or medical history which your doctor will explain to you.

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology

Summary: Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for non metastatic colon cancer.


Eligibility: Inclusion Criteria:
  -  Colectomy for Non metastatic colon cancer
  Exclusion Criteria:
  -  Tumor T4
  -  No medical insurance
  -  Pregnant woman
  -  Psychiatric disorders

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer

Summary: A randomized controlled clinical trial to compare the short and long outcomes of Neoadjuvant chemotherapy with postoperative chemotherapy in patients with resectable locally advanced colon cancer

Detailed description: For resectable locally advanced colon cancer, the preferred treatment is colectomy with en bloc removal of the regional lymph nodes followed by chemotherapy of about 6 months. However, surgery may postpone the administration of chemotherapy due to postoperative complications such as anastomosis leakage, abdominal infection, thus leads to a poor survival. Some scholars suggested that for patients with locally advanced colon cancer, chemotherapy given before surgery might shrink or downstage tumor, facilitate surgery and promote a better oncological outcome. Whether adjuvant chemotherapy benefits these patients with better outcome still remains controversial.
  In this study, eligible patients will be randomly allocated to receive either adjuvant chemotherapy or not. For patients receiving adjuvant chemotherapy, surgery will be performed 3-4 weeks later. Preoperative and postoperative chemotherapy will be given for a total of about 6 months. For patients receiving no preoperative chemotherapy, chemotherapy will be given for about 6 months postoperatively. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively.

Eligibility: Inclusion Criteria:
  -  Patients suitable for curative surgery between 18 to 80 years old;
  -  American Society of Anesthesiologists(ASA) grade I-III;
  -  Pathological diagnosis of adenocarcinoma;
  -  Tumor located between the cecum and sigmoid colon;
  -  Enhanced CT scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is T3-T4 N0 or T any N+ (according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis;
  -  Informed consent;
  -  No preoperative chemoradiotherapy;
  -  No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
  Exclusion Criteria:
  -  Pregnant patient;
  -  History of psychiatric disease;
  -  Use of systemic steroids;
  -  Simultaneous multiple primary colorectal cancer;
  -  Preoperative imaging examination results show:
  1. distant metastasis;
  2. unable to perform R0 resection;
  -  Postoperative pathology of T1-T2 N0;
  -  History of any other malignant tumor in recent 5 years;
  -  Patients need emergency operation: mechanic ileus, perforation.

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study

Summary: This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and detecting tumor tissues, peripheral blood samples and urine samples of NSCLC patients.

Detailed description: Liquid biopsy, specifically through the assessment of circulating tumor DNA(ctDNA) from peripheral blood, has shown great promise in lung cancer diagnosis and therapeutic monitoring.
  Urinary samples are completely non-invasive and easily obtainable compared to blood and tissue extraction. To date, only a limited number of published studies have examined the feasibility of ctDNA detection from urine.
  This study will collect tumor tissues, pretreatment peripheral blood samples and urine samples from different TNM stages of NSCLC patients, and detect EGFR gene mutations in paired samples.

Eligibility: Inclusion Criteria:
  -  Aged 18 to 80 years
  -  Histologically confirmed diagnosis of stage non-small cell lung cancer undergoing surgical resection
  -  Completed and explicit information about TNM staging
  -  Paired specimens including tumor tissues, and both peripheral blood samples and urinary samples before and after surgery.
  -  Patients must have given written informed consent
  Exclusion Criteria:
  -  Unable to comply with the study procedure
  -  Malignant tumor history within the past 5 years
  -  Coexisting small cell lung cancer
  -  Unqualified tissue, blood or urine samples

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer

Summary: The T-REX study aims to clarify the actual status of metastatic lymph node (LN) distribution in colon cancer and provide reliable evidence regarding the optimal length of bowel resection and the extent of central lymph node dissection in colon cancer surgery.

Detailed description: In colon canser, the incidence of metastasis in the pericolic lymph nodes (LNs) located along the bowel and marginal artery is high. The optimal extent of bowel resection is closely associated with how we define 'regional' pericolic LNs, which should be resected because of the risk of metastasis. However, there are no standardised criteria for 'regional' LNs in the pericolic area.
  To establish a consensus for the extent of bowel resection and appropriate central LN dissection, international prospective stdies focusing on the distribution of metastatic LNs along the bowel and the primary feeding artery are conducted.

Eligibility: Inclusion Criteria:
  -  Histologically proven colon adenocarcinoma
  -  Pathological stage Ⅰ, Ⅱ or Ⅲ
  -  Potentially curative surgery
  -  Informed consent for observational data collection
  Exclusion Criteria:
  -  Tis (mucosal cancer)
  -  Multiple colon cancers
  -  All patients with preoperative adjuvant therapy

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Laparoscopic Versus Open Right Hemicolectomy Within ERAS in Right-sided Colon Cancer

Summary: In this study, the investigators have compared the clinical outcomes of the laparoscopic and open right hemicolectomy within enhanced recovery after surgery (ERAS) programs in the treatment of right-sided colon cancer.


Eligibility: Inclusion Criteria:
  1. Age ≥ 18 and ≤ 75 years;
  2. Primary tumor has undergone histologically confirmed colon adenocarcinoma; Colon cancer was defined by the presence of the inferior pole of the tumor above the peritoneal reflection (at least 15 cm from the anal margin).
  3. Together with clinical or radiological evidence of Stage(T1-2,N0, M0) Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2007 revision of the International Union Against Cancer TNM staging system)
  4. Performance status (ECOG) 0~1
  5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
  6. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
  7. Written informed consent for participation in the trial.
  Exclusion Criteria:
  1. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
  2. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
  3. Known drug abuse/ alcohol abuse
  4. Legal incapacity or limited legal capacity
  5. Pre-existing peripheral neuropathy.

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: A Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach

Summary: To investigate the clinical application value of laparoscopic radical right hemicolectomy using the caudal-to-cranial approach versus the medial-to-lateral approach by prospective randomized controlled clinical study.

Detailed description: To compare the caudal-to-cranial approach with the medial-to-lateral approach in laparoscopic right hemicolectomy for the advance right colon cancer.
  A prospective randomized controlled trial will be performed in the GI department,the Guangdong provincial hospital of Chinese Medicine from October 2016 to October 2024.The sample size，150 cases with advanced right colon cancer, will be needed after calculated by the statistics .The 150 cases will be randomly divided into two groups: laparoscopic radical right hemicolectomy using the caudal-to-cranial(CtC) approach(GroupCtC) and laparoscopic radical right hemicolectomy using the medial-to-lateral(MtL) approach (GroupMtL). Primary outcomes are the operative time，The secondary outcomes are the total blood loss,the number of lymph nodes dissected,the average time of ground activities,the time to first flatus,the hospital stay,the intra-operative complication and the post-operative complication，and others' outcomes are the Disease-free survival rate(DFS) at 3 years and 5 years,the Overall survival rate（OS）at 3 years and 5 years.The data in two groups will be compared.

Eligibility: Inclusion Criteria:
  1. The age limits is 18-80 years old;
  2. The clinical staging was II,III carcinoma of right colon，located in right-sided colon;
  3. The preoperative imaging confirmed that the tumor did not involve adjacent organs;
  4. American Society of anesthesiologists (ASA) score less than or equal to Level III;
  5. Criteria of performance status karnofsky is greater than or equal to 60.
  Exclusion Criteria:
  1. The patients' age limits is Less than 18 years old, or more than 80 years old
  2. The preoperative imaging confirmed that the tumor involve adjacent organs;
  3. The tumor have been finding distant metastases;
  4. American Society of anesthesiologists (ASA) score more than 3;
  5. Criteria of performance status karnofsky is lower than 60;
  6. It is the carcinoma of right colon with multiple colonic polyps Disease;
  7. there is a laparoscopic surgery contraindications.

Relevance to patient case: not relevant