araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors

Summary: This study is based on the following hypothesis "De novo resistance to EGFR-TKI in EGFR mutation positive patients is related with mutations in EGFR downstream genes".
  Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification, and protein over expression as predictive markers of treatment outcomes, investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression. Investigators will attempt to identify biomarkers that are able to predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.

Detailed description: Investigators will prospectively enroll patients who match the following criteria: pathologically proven unresectable NSCLC, planning to treat with EGFR-TKI, patients with activating EGFR mutations, and available tissue sample for DNA extraction.

Eligibility: Inclusion Criteria:
  1. Pathologically proven unresectable NSCLC
  2. 20 years of age or older
  3. Planned treatment with Iressa®
  4. Patients with activating EGFR mutation (del 19, L858R)
  5. Available detailed smoking history
  6. Available tissue samples (archival tissue) for mutational or molecular analysis (representative paraffin block or unstained sections from tumor diagnostic specimen are mandatory)
  7. Available blood sample
  8. At least one lesion that is measurable according to the RECIST 1.1 criteria by CT or MRI
  9. Written informed consent
  Exclusion Criteria:
  1. More than 3rd line treatment
  2. Previously treated with other EGFR-TKI
  3. Life expectancy of less than 12 weeks
  4. Pregnant or lactating female
  5. Any unresolved toxicity greater than CTC grade 2 (version 4.0) from previous anti cancer treatment.
  6. Unsuitable patient in this treatment as determined by doctor.

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Trial of Postoperative Chemoradiotherapy With or Without Consolidation Chemotherapy for Cervical Cancer Patients

Summary: The purpose of this study is to determine the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage cervical cancer.

Detailed description: Cervical carcinoma is one of the most common gynecologic cancers worldwide. Early stage cervical cancer can be treated effectively with either radiotherapy or radical hysterectomy plus pelvic lymph node dissection. However, several pathological risk factors, such as lymph node metastasis, the involvement of vaginal resection margin, and the parametrial invasion, have been identified to compromise the patient prognosis.
  Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, many patients with pathological risk factors treated with concurrent radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.
  Paclitaxel has been demonstrated to be a good radiosensitizer. In addition, paclitaxel/cisplatin combination chemotherapy was demonstrated to have superior progression-free survival than platinum alone in some phase Ⅱ studies. In addition, it is not yet known whether chemotherapy and radiation therapy are more effective when given with consolidation chemotherapy in treating cervical cancer.
  Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemotherapy and radiotherapy with consolidation chemotherapy in high-risk patients with early-stage cervical cancer following radical hysterectomy.

Eligibility: Inclusion Criteria:
  -  Undertaken radical hysterectomy with diagnosis of invasive cervical cancer I a2-II b (non-small cell type)
  -  One or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement)
  -  Eastern Cooperative Oncology Group 0-2
  -  Expected life span over 6 months.
  -  No distant metastasis
  -  Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)
  -  Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
  -  Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)
  -  Written informed consent
  Exclusion Criteria:
  -  Previous history of chemotherapy or radiation
  -  Hypersensitive reaction to platinum/paclitaxel agent
  -  History of other cancer
  -  Concurrent systemic illness not appropriate for chemotherapy
  -  Active infection requiring antibiotics
  -  Pregnancy
  -  Metastasis to paraaortic lymph node

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients

Summary: We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical cancer patients with risk factors.


Eligibility: Inclusion Criteria:
  -  FIGO stage: ⅠB～ⅡA, cervical cancer;
  -  Age≤60 years; female, Chinese women;
  -  Initial treatment is radical hysterectomy + pelvic lymph node dissection;
  -  Pathological diagnosis: cervical squamous cell invasive carcinoma;
  -  Pathologic examination and meet the following one of the indications of adjuvant therapy: ① lymph node metastasis, ② parametrial invasion, ③ ≥ 2/3 deep stromal invasion, ④ histopathological grading in poorly differentiated (G2 to G3), ⑤ lymphatic vascular space involvement, ⑥ tumor diameter> 4cm;
  -  Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
  -  Performance status: Karnofsky score≥60;
  -  No prior treatment;
  -  Receiving extensive resection of uterus (type III) plus pelvic lymph nodes wide resection; pathologically diagnosed with cervical squamous cell carcinoma;
  -  Provide written informed consent.
  Exclusion Criteria:
  -  With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy
  -  History of organ transplantation, immune diseases;
  -  History of serious mental illness, a history of brain dysfunction;
  -  Drug abuse or a history of drug abuse;
  -  Suffering from other malignancies;
  -  Concurrently participating in other clinical trials
  -  Unable or unwilling to sign informed consents;
  -  Unable or unwilling to abide by protocol.

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Postoperative Chemoradiation v.s Radiotherapy for Lymph Node Negative Cervical Cancer Patients

Summary: This phase III study is designed to examine if low-risk (lymph node negative), stage I a2-II b cervical cancer patients treated by paclitaxel/cisplatin chemoradiation have greater toxicities but similar survival rate as those treated by radiotherapy alone.

Detailed description: Cervical carcinoma is one of the most common gynecologic cancers worldwide. Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with high risk factors cervical cancer. However, the treatment modality in patients with low-risk (lymph node negative) is still disputable. It is not yet known whether cisplatin-based chemoradiotherapy are more effective than radiotherapy alone in treating these patients.
  Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemoradiotherapy vs. radiotherapy alone in lymph node negative patients with early-stage cervical cancer following radical hysterectomy.

Eligibility: Inclusion Criteria:
  -  Undertaken radical hysterectomy with diagnosis of invasive cervical cancer (non-small cell type)
  -  Negative lymph node
  -  At least two risk factors (interstitial infiltration of greater than 1/3, vascular or lymphatic involvement, cervix neoplasms larger than 4 cm, nerve involvement)
  -  Eastern Cooperative Oncology Group 0-2
  -  Expected life span over 6 months.
  -  No distant metastasis
  -  Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)
  -  Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
  -  Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)
  -  Written informed consent
  Exclusion Criteria:
  -  Previous history of chemotherapy or radiation
  -  Hypersensitive reaction to platinum/paclitaxel agent
  -  History of other cancer
  -  Concurrent systemic illness not appropriate for chemotherapy
  -  Active infection requiring antibiotics
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: MeFirst: A Tailored Intervention to HPV Vaccine Decision Making

Summary: This study will test whether a tailored, online educational intervention increases HPV vaccine uptake and intent among female college students.

Detailed description: MeFirst is the first web-based, online, educational tool designed to promote Human Papillomavirus (HPV) vaccine awareness and understanding in an effort to improve HPV vaccine intent and uptake among female university students. HPV is the most common sexually transmitted infection and causes genital warts and cancer. The HPV vaccine has been recommended for girls ages 11-26 since 2006, yet vaccination rates remain low. Tailored online interventions may be more effective tools to promote behavior change among college students than traditional static interventions. The proposed study is a randomized controlled trial testing the efficacy of the MeFirst tool vs. standard static educational material on increasing HPV vaccination intent and uptake among female university students aged 18-26.

Eligibility: Inclusion Criteria:
  -  enrolled at the University of Michigan
  Exclusion Criteria:
  -  receipt of any doses of HPV vaccine

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Significance of Fluorescence Colposcopy With Autofluorescence Imaging for Cervical Cancer

Summary: Clinical Trial to access Significance of fluorescence colposcopy with autofluorescence imaging for the screening of cervical cancer

Detailed description: 1. Perform pelvic vaginal exam of the subjective to know symptom, illness history, physical exam and basal state before fluorescence colposcopy.
  2. Observe acetowhite epithelium and perform biopsy at suspicious lesion during fluorescence colposcopy.
  3. Perform fluorescence colposcopy again after biopsy and confirm extraordinary reaction.
  4. After 1~2weeks follow up the subjective at opd and confirm biopsy result.

Eligibility: Inclusion Criteria:
  1. age : 20-65 years
  2. abnormal cervical papanicolaou smear , no other specific cervical disease
  3. subject to colposcopic biopsy or LEEP
  4. signed voluntarily to informed concents with full knowledge after explanation abot objective, method, contents
  Exclusion Criteria:
  1. pregnant women
  2. porphyria
  3. severe cervical bleeding
  4. genital chlamydia, gonorrhea infection
  5. other drug user with possible interaction (e.g. photosensitizer)
  6. no informed consent

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)

Summary: A study to evaluate the efficacy, immunogenicity, and tolerability of V501 (quadrivalent Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.


Eligibility: Inclusion Criteria:
  -  Japanese
  -  No clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts
  -  Other inclusion criteria will be discussed with the investigator during screening
  Exclusion Criteria:
  -  History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
  -  History of external genital warts
  -  History of severe allergic reaction that required medical intervention
  -  Received immune globulin or blood-derived products in the past 6 months or plan to receive any before Month 7 of the study
  -  History of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, Human Immunodeficiency Virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
  -  Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
  -  Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
  -  Ongoing alcohol or drug abuse within the past 12 months

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: MRI FDG PET Imaging Cervix

Summary: The standard treatment for cervix cancer at Princess Margaret Hospital is external radiation with chemotherapy followed by internal radiation, called brachytherapy. Currently, brachytherapy treatment is planned on a type of Magnetic Resonance Imaging (MRI) called T2-weighted (T2W) MRI.
  The main purpose of this study is to determine whether the following imaging tests can visualize the tumor better for planning the brachytherapy treatment:
  1. special types of MRI called diffusion weighted MRI (DWI) and dynamic-contrast enhanced MRI (DCE-MRI); and
  2. an x-ray test called positron emission test (PET) performed with a sugar dye called FDG. MRI-guided brachytherapy is resource-intensive and not widely available.


Eligibility: Inclusion Criteria:
  1. Age ≥ 18 years
  2. Histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix
  3. FIGO Stage IB - IVA
  4. Intention to treat using radiotherapy with or without concurrent cisplatin chemotherapy according to the current treatment policies of the PMH Gynecology Group
  5. Intention to treat with MR-guided brachytherapy as part of standard radiotherapy according to the current treatment policies of the PMH Gynecology Group
  6. No cytotoxic anti-cancer therapy for cervix cancer prior to study entry
  7. A negative urine or serum pregnancy test within the two week interval immediately prior to the first PET-CT imaging, in women of child-bearing age
  8. Ability to provide written informed consent to participate in the study
  Exclusion Criteria:
  1. Prior complete or partial hysterectomy
  2. Carcinoma of the cervical stump
  3. Inability to lie supine for more than 30 minutes
  4. Insulin-dependent diabetes mellitus
  5. Impaired kidney function with glomerular filtration rate < 30
  6. Previous anaphylactic reaction to gadolinium or other contraindications to MR.

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer During Radiation or Chemoradiation Therapy

Summary: The impact of sonifilan on the quality of life in patients with cervical cancer during radiation or chemoradiation therapy
  1. Primary endpoint : Quality of life
  2. Secondary endpoint : complications related to Sonifilan, treatment effect of Sonifilan

Detailed description: Study design Prospective randomized controlled trial
  Study period Protocol registration approval date - may/31/2016
  Study drug Sonifilan(Sizofiran)
  Study population
  1. Cervical cancer FIGO stage IA2-IVA patients will be participated.
  2. Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma
  3. age 20-75 year
  Treatment Fron the day of radiation therapy started, Sonifilan 20mg, 1amp IM/week for 8weeks
  Concurrent therapy Chemo & radiation therapy
  1. Cisplatin 40mg/m2, day 1, 8, 15, 2, 29, 36
  2. External whole pelvic irradiation 3000-3500 cGy / 6 fractions in high dose rate
  Assessment
  1. Pre-study assessment (within 4weeks before participation) a medical history b informed consent c ID number assignment d life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI e basic information collect
  2. On-study assessment (during study) a complication check b life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI
  3. Post-study assessment (1week after study finished) a MRI b PAP smear c HPV test d life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI
  4 Follow-up assessment (every 3 month for 1 year) a Pelvic exam b PAP smear c HPV test d MRI (if needed) e PET (if needed) f life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI 93, 6, 12, 24 month after study finished)

Eligibility: Inclusion Criteria:
  -  Cervical cancer FIGO stage IA2 - IVA
  -  Histologic type : SCC, Adenocarcinoma, Adenosquamous carcinoma
  -  GOG performance status 0-2
  Exclusion Criteria:
  -  past radiation therapy history
  -  Neuroendocrine carcinoma
  -  concurrent other cancer
  -  uncontrolled medical disease
  -  ulcerative disease history
  -  current pregnancy and lactation

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL

Summary: Cervical cancer occurs commonly in HIV-infected women in South Africa. These women have poor response to treatment of cervical cancer precursors. This study will test whether giving the quadrivalent vaccine to women prior to surgical treatment of the cervical cancer precursor will improve outcomes. We hypothesize that pre-treatment HPV vaccine will result in a reduced occurrence or cervical cancer precursors in follow-up.

Detailed description: This is a single-center, randomized, double-blinded, placebo-controlled, phase II trial of the quadrivalent human papillomavirus vaccine (qHPV) in HIV-infected women to prevent occurrence of cervical HSIL after LEEP/LLETZ. Participants will undergo colposcopy with directed biopsies, cervical cytology, and stored HPV testing prior to vaccination. Participants will be randomized to the quadrivalent vaccine or saline placebo to be given at entry, week 4, and week 26. Women will have LEEP treatment at week 4. Participants will be seen in follow-up for cervical cytology, colposcopy with directed biopsies at weeks 26 and 52, and stored HPV specimens. Treatment assignment will be unblinded after study follow-up is completed for the last study participant. Women aged 45 or less randomized to placebo will be offered open label HPV vaccine after the study is concluded..

Eligibility: Inclusion Criteria:
  1. HIV infection
  2. Women aged ≥ 18 years.
  3. Cervical HSIL on biopsy (i.e. CIN2 and/or CIN3)
  4. For participants of reproductive potential, negative serum or urine pregnancy test
  5. All study participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or in vitro fertilization) during study participation (from the time of study entry until week 52).
  Exclusion Criteria:
  1. History or current biopsy diagnosis of invasive or microinvasive cervical, vaginal, vulvar, anal or oropharyngeal cancer
  2. Prior hysterectomy
  3. Cervical cryotherapy or LEEP/LEETZ within one year of entry.
  4. Cervical, vulvar, or vaginal lesions suspicious for cancer, unless biopsies show no invasive cancer
  5. Prior receipt of one or more doses of an HPV vaccine.
  6. Receipt of anticoagulants other than aspirin or nonsteroidal anti-inflammatory drugs (NSAIDS) within 14 days prior to entry.
  7. Known allergy/sensitivity or any hypersensitivity to yeast or any of the components of the study product or its formulation (see section 5.2 for a list of components).
  8. Hemophilia or other bleeding diatheses.
  9. Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, other than inhaled corticosteroids or prednisone ≤ 10 mg (or equivalent) , investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry.
  10. Breastfeeding
  11. Less than 3 months post-partum

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Apparent Diffusion Coefficient as a Prognostic Biomarker in Cervical Cancer

Summary: This study aims to develop the technique of Diffusion-Weighted Magnetic Resonance Imaging(DW-MRI)for the assessment of stage 1 cervical cancers. An endovaginal receiver coil has been designed and developed at the Institute of Cancer Research and Royal Marsden NHS Foundation Trust for use at high field strengths(3T). This will be used to evaluate if DW-MRI at 3T can be used to differentiate different histological characteristics within whole tumours and so determine if the technique could be of prognostic value.
  The study hypothesis is that this technique will be able to differentiate tumours with histological features known to be associated with poor prognosis (tumour type, grade and lymphovascular space invasion).


Eligibility: Inclusion Criteria:
  -  All patients with presumed early stage cervical cancer being considered for curative surgery
  Exclusion Criteria:
  -  Ferromagnetic metal implants
  -  claustrophobia (MRI incompatibility)

Relevance to patient case: not relevant