araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention

Summary: The purpose of this study is to learn if a cervical health literacy program is a practical and helpful way of improving women's cervical health knowledge and improving cancer screening behaviors, and ultimately preventing cervical cancer.

Detailed description: Women in the criminal just system are 4-5 times more likely to have cervical cancer than non-incarcerated women. Little is known about how to close this gap. The few investigators that have studied cervical cancer risk and disease among women in jails and prisons have found that while many women get screened for cervical cancer, less than half get follow-up care.
  The investigator's pilot research suggests the most important contributor to cervical cancer risk, and perhaps lack of follow-up, is incarcerated women's low health literacy about both cervical cancer and broader reproductive health issues. This study is testing a sexual health empowerment intervention (SHE Project) to see if it improves incarcerated women's reproductive health literacy.

Eligibility: Inclusion Criteria:
  -  Women sentenced or anticipate a sentence of one year or less
  -  Ability to follow participants post-jail release
  -  Able to read and understand English
  Exclusion Criteria:
  -  Women who have been treated for cervical cancer with procedures that would obviate the need for regular screening
  -  Exhibit severe psychological distress

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: ADXS11-001 High Dose HPV+ Cervical Cancer

Summary: To evaluate the tolerability and safety of ADXS11-001 (1 x 10^10 colony forming units [cfu]) administered with prophylactic premedication in repeating 3-dose study cycles in women with persistent, metastatic, or recurrent squamous and non-squamous carcinoma, adenosquamous, or adenocarcinoma of the cervix. To evaluate tumor response and progression-free survival (PFS, time to progression) by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).


Eligibility: Inclusion Criteria:
  -  Patients with histologically-confirmed, persistent, metastatic or recurrent squamous or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease progression (disease not amenable to surgery or standard radiotherapy).
  -  Patients who have received no more than 1 prior cytotoxic treatment regimen.
  -  Subject may have received ≤2 prior regimens for the treatment of their metastatic disease.
  -  Subject is able to provide written informed consent.
  -  Subject must have an ECOG performance status of 0 or 1.
  Exclusion Criteria:
  -  In the opinion of the investigator, subject has rapidly progressing disease, OR has life expectancy of less than 6 months, OR would be unable to receive at least one cycle of therapy.
  -  Subject has received chemotherapy and/or radiation therapy (except palliative radiation therapy for disease-related pain) within ≤2 weeks of first ADXS11-001 infusion.
  -  Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  -  Has a contraindication to administration of trimethoprim/sulfamethoxazole or ampicillin.
  -  Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant.

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: NGS Genome Analysis in Personalisation of Lung Cancer Treatment

Summary: The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer remission in some patients, but use of the EGFR-TKIs is limited to patients with adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has become an increasingly important cause of treatment failure. Therefore, identification of the molecular components involved could lead to the development of effective therapy. Today only a limited number of genetic alterations are studied.
  Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation detection.


Eligibility: Inclusion Criteria:
  -  patients of bronchial adénocarcinoma with metastases can benefit from first-line therapy - targeted therapy by tyrosine kinase inhibitor(TKI) for EGFR mutation and chemotherapy for non EGFR mutation)
  -  Patients with epidermoid cancer of the lungs can benefit from chemotherapy
  -  man and women
  -  age ≥ 18 years
  -  Patients have signed a written informed consent form
  -  Patients are affiliated to s social health insurance
  Exclusion Criteria:
  -  Survival time ≤ 3 months
  -  Patients with cerebral metastases
  -  Patients could not benefit from treatment for others diseases
  -  Pregnancy or breast-feeding
  -  Incapacity to sign the consent form for psychiatric, behavioural disorders
  -  Private individuals of freedom or under tutelage

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer

Summary: Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium, germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.
  Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor may provide improved therapeutic benefit compared with inhibitors that target only one or the other receptor.
  Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients with HER2-positive refractory cancer.


Eligibility: Inclusion Criteria:
  -  Age > 19
  -  Written informed consent
  -  ECOG 0-2,
  -  Histologically confirmed HER2-positive Refractory solid tumor(IHC 3+ alone, or IHC 2+ with FISH amplification) and/or specific sensitivity to Lapatinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  The presence of measurable disease as defined by the Response (Evaluation Criteria in Solid Tumors (RECIST) version 1.1)
  -  Adequate organ function
  Exclusion Criteria:
  -  Uncontrolled symptomatic brain metastasis,Uncontrolled active infection
  -  Uncontrolled systemic illness (DM, CHF, unstable angina, hypertension or arrhythmia)
  -  Prolonged QT interval in ECG (QTc >450 msec)
  -  Pregnant, lactating women
  -  Prior treatment with lapatinib,Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication
  -  Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors

Summary: This is a Phase 1b, multicenter, open-label, dose-escalation study designed to estimate the maximum tolerated dose (MTD) and determine the recommended Phase 2 dose (RP2D) of ADXS31-164. Once the RP2D has been selected, up to 4 expansion cohorts will be evaluated.


Eligibility: Inclusion Criteria:
  -  HER2 Positive
  -  Have histological or cytological diagnosis of locally advanced/metastatic HER2 solid tumors that has progressed or become intolerant to standard therapy or for which no standard therapy is available
  -  Have measurable and/or evaluable disease based on RECIST 1.1.
  -  ECOG performance status of 0 to 1
  Exclusion Criteria:
  -  Is newly diagnosed with a curative treatment option available.
  -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of' immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  -  Has had a prior monoclonal antibody therapy within 2 weeks prior to study Day 1. (Prior anti-HER2 therapy is acceptable).
  -  Has received anticancer chemotherapy, surgical treatment, and/or radiation therapy (except palliative radiation therapy for disease-related pain with a consult with the sponsor's medical monitor) within ≤2 weeks of first study treatment.
  -  Is dependent on, currently or has received within the past 4 weeks corticosteroids (hormone replacement therapy, topical corticosteroids and occasional inhaled corticosteroids are allowed).
  -  Has a contraindication to administration of trimethoprim/sulfamethoxazole or ampicillin.
  -  Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant.

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

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

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


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

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Pilot Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With HER-2 Positive Metastatic Cancer

Summary: Immune-based therapies (vaccines) are a new focus of clinical investigation. These therapies try to assist a patient's immune system (a system in our bodies that protects us against infection) in killing tumors. One form of such therapy is the dendritic cell combined with HER-2/neu (a type of protein over-expressed in some cancers) vaccine. Dendritic cells are immune cells that can tell your immune system to fight infection. In laboratory testing, these cells may also help the immune system attack tumors such as breast, kidney cancer or skin cancer. The purpose of this research study is to determine if it is both possible and safe to administer" this vaccine to patients with any HER2+ cancer.

Detailed description: We have demonstrated that administration of HER-2/neu pulsed DC1 in patients with DCIS results in strong immunologic responses as well as clinical responses during a brief 4 or 6 week neoadjuvant vaccination. In subsets of patients with cancer HER-2 is over-expressed including subsets of breast, gastric, pancreatic, brain, lung, and colon cancer. This trial is designed for compassionate use of a HER-2/neu pulsed DC1 in patients with metastatic HER-2 positive cancer, who have no longer standard options to eliminate disease.

Eligibility: Inclusion Criteria:
  1. Age ≥ 18 years.
  2. Subjects with active metastatic HER-2 positive cancer, at least 1+ by IHC, that have already received standard therapy who have exhausted other treatment options.
  3. Subjects with HER-2 1+ need to be HLA 2 or HLA A3 positive. There are no HLA restrictions for HER-2 2+ or 3+.
  4. Women of childbearing age with a negative pregnancy test documented prior to enrollment.
  5. Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D).
  6. Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study.
  7. Subjects who have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.
  -
  Exclusion Criteria:
  1. Pregnant or lactating females.
  2. Subjects with positive HIV or hepatitis C at baseline by self report.
  3. Subjects with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec
  4. Subjects with major cardiac illness MUGA or ECHO < 50% EF.
  5. Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by PI.
  6. Subjects receiving current therapy that may suppress immune system, such as steroids, chemotherapy at the discretion of the PI.

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Use of SMSs to Improve Attendance to Cervical Cancer Follow-up Screening

Summary: This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.

Detailed description: Connected2Care is a non-blinded, multicentre, parallel-group, randomised controlled trial. Tanzanian Women testing positive to HR HPV at inclusion are randomly assigned in an allocation ratio of 1:1 to the SMS intervention or the control group (standard care). In a period of 10 months, the intervention group will receive 15 one-directional health educative text messages and SMS-reminders for their appointment. The total sample size will be 700 with 350 women in each study arm. Primary outcome is attendance rate for follow-up. Secondary objectives are cost-effectiveness measured through incremental ratios and knowledge of cervical cancer by a 16-item true/false scale questionnaire at baseline and follow-up.

Eligibility: Inclusion Criteria:
  -  Informed consent
  -  HPV positive
  -  Age 25 - 60 years
  -  Private mobile phone
  Exclusion Criteria:
  -  Pregnant on day of enrolment
  -  Menstruating on day of enrolment
  -  Hysterectomy
  -  Diagnosed with cervical pre-cancer within past 12 months
  -  Diagnosed with cervical cancer
  -  Invalid mobile phone number
  -  Unreachable when trying to convey HPV positive result

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy

Summary: The purpose of this trial is to assess the anti-tumour activity and safety of afatinib monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 mutations or ERBB2 amplifications (Cohort A), and EGFR amplification positive tumours (Cohort B), progressing despite previous platinum based chemotherapy, and thereby to improve their prognosis.
  The antitumour activity of afatinib monotherapy in these patients will be assessed by progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the trial. A key secondary endpoint will also be defined, the objective response rate (ORR).


Eligibility: Inclusion criteria:
  -  Recurrent or metastatic urothelial cancer
  -  Patients must have failed prior platinum based treatment (adjuvant or 1st line)
  -  Archival tissue sample available for biomarker testing at pre-screening and tissue banking.
  -  Patients should complete a pre-screening biomarker analysis and should fulfill the following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should show EGFR (Epidermal Growth Factor Receptor) amplification.
  -  Further inclusion criteria apply
  Exclusion criteria:
  -  Prior use of EGFR, ERBB2 or ERBB3 targeted treatment
  -  Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first
  -  Known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis
  -  Further exclusion criteria apply

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: An Innovative Treatment for Cervical Pre Cancer

Summary: The purpose of this study is to test two innovative devices, the CryoPen® and thermocoagulator, against gas-based cryotherapy to determine whether the novel devices produce equivalent or improved destruction of cervical tissue compared to gas-based cryotherapy. Tissue destruction with single freeze versus double freeze treatments with the CryoPen and gas-based cryotherapy will also be compared.

Detailed description: The primary objectives of the study are to test the hypothesis that the CryoPen® and thermocoagulator provide a non-inferior depth of cervical tissue necrosis compared with traditional CO2-based cryotherapy and to test single versus double freeze applications. The secondary objectives of the study are to determine if the CryoPen® or thermocoagulator achieves a depth of necrosis of 3.5 mm, the accepted depth required for eradicating 95% of cervical precancer, and to observe the relationship between depth of necrosis and variations in cervical anatomy.

Eligibility: Inclusion Criteria:
  -  Between 25 and 65 years old.
  -  Scheduled for a hysterectomy for reasons other than cervical precancer or cancer
  -  Diagnosis of uterine, endometrial, ovarian or other cancer that does not jeopardize the tissue of the cervix is permitted
  -  Histological evaluation of the cervix does not interfere with the woman's current diagnosis
  -  Woman consents to participate after being informed about the study
  -  Normal Pap Smear or HPV test in the past 3 years
  Exclusion Criteria:
  -  Pregnancy
  -  History of cervical surgery in past 5 years
  -  Presence of cervical lesion pre-invasive or invasive on the cervix *
  -  Current Pelvic Inflammatory Disorder or severe acute cervicitis
  -  Cervix shape disfigured or hard to reach

Relevance to patient case: not relevant