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

Clinical trial: A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

Summary: This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the Base Study. Participants who receive placebo in the Base Study will be eligible to receive vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.


Eligibility: Inclusion Criteria:
  Participants Age 12 to 15 Years:
  -  Participant is in good health
  -  Parent/legal guardian and participant agree to provide study personnel with a primary telephone number for follow-up
  -  Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
  -  Participant has not received any other HPV vaccine
  -  Participant is not yet sexually active
  Participants Age 16 to 26 Years:
  -  Participant is in good health
  -  Participant agrees to provide a primary telephone number for follow-up
  -  Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
  -  Participant has not received any other HPV vaccine
  -  Participant has never had Papanicolaou (Pap) testing or has only had normal results
  -  Participant has a history of 0 to 4 lifetime sexual partners at enrollment
  Exclusion Criteria:
  All participants:
  -  Participant has a history of severe allergic reaction that required medical intervention
  -  Participant has any disorder that would contraindicate intramuscular injections
  -  Participant is pregnant
  -  Participant is immunocompromised or has an autoimmune condition
  -  Participant has had a splenectomy
  -  Participant has received any immune globulin product or blood-derived product
  -  Participant has participated in a HPV vaccine clinical trial
  Participants Age 16 to 26 Only:
  -  Participant expects to donate eggs during the study
  -  Participant has a history of abnormal cervical biopsy result
  -  Participant has a history of HPV-related external genital lesions, external genital cancer, HPV-related vaginal lesions, or vaginal cancer

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

Clinical trial: Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in Cervical Cancer Patients

Summary: Cervical cancer is a major health problem for Chinese women. It is estimated that nearly 100,000 new cervical cancer cases occur in China every year, which accounts for about 20 percent of global new cases. Surgery and radiotherapy are two major radical treatment methods for IB-IIB cervical cancer. Unlike the United States and some other countries, most of operable women with IB-IIB cervical cancer received radical surgery other than radiotherapy in China. Patients with recurrence risk factors (lymph node metastasis, deep stromal invasion, positive lymphatic vascular space, et al. ) also received adjuvant therapy after surgery, such as radiotherapy or chemoradiotherapy that are recommended in the NCCN guidelines. However, in China a substantial part of patients especially those admitted to tertiary hospitals received several courses of chemotherapy instead of radiotherapy if they had recurrence risk factors .
  In our previous study, we found that patients with intermediate risk factors (deep stromal invasion, positive lymphatic vascular space, bulky tumor>4cm) had better disease-free survival and recurrence-free survival when they received chemotherapy compared with radiotherapy. The objective in this study is to investigate whether the advantage of postoperative chemotherapy is a result of circulating tumor cells (CTC) in some of the patients with intermediate risk factors.


Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed Ib~IIa （FIGO）cervical carcinoma without previous treatments
  -  Age between 18-70
  -  With the presence of these three pathological risk factors after radical surgery:(1) positive lymphatic vascular space,(2)outer one-third invasion of the cervical stroma, (3) bulky tumor≥4cm
  -  At least 3 months of disease-free survival
  Exclusion Criteria:
  -  The presence of other uncontrolled life-threatening disease (Suffering from myocardial infarction or stroke, or unstable angina, decompensated heart failure, or a history of deep vein thrombosis)
  -  Receiving other anti-cancer therapy, such as traditional Chinese drug
  -  Don't be able to finish the whole treatment(chemotherapy or radiotherapy)
  -  liver dysfunction (ALT、AST>2.5×ULN)
  -  renal dysfunction (Creatinine>1.5×ULN)
  -  WBC<4,000/mm3 or PLT<100,000/mm3
  -  Received preoperative radiotherapy

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

Clinical trial: Studying Biomarkers in Blood Samples From Patients With Invasive Cervical Cancer

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.
  PURPOSE: This research study is looking at biomarkers in blood samples from patients with invasive cervical cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To develop a serum proteomic profile for cervical cancer using banked pre-treatment serum specimens from patients with invasive cervical cancer and to determine if this serum proteomic profile has possible utility in cervical cancer prognosis.
  Secondary
  -  To develop a serum proteomic profile for cervical cancer using banked post-treatment serum specimens from these patients and to determine if this serum proteomic profile has possible utility in cervical cancer prognosis.
  OUTLINE: This is a multicenter study.
  Banked serum specimens are used to generate proteomic profiles.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed invasive adenocarcinoma, squamous cell carcinoma, or adenosquamous cell carcinoma of the cervix
  -  Stage IIB, III, or IVA disease
  -  Eligible and evaluable for GOG-0191
  -  Pre- and/or post-treatment serum specimens available for proteomic analysis
  PATIENT CHARACTERISTICS:
  -  Patient has given consent to allow their specimen(s) to be used for future cancer research
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: FLT PET Imaging for Cervical Cancer

Summary: Our primary hypothesis is that [18F]FLT PET can identify active bone marrow in addition to metabolically active tumor.
  This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The radiation plan is then designed to spare that area, in hopes of keeping the bone marrow active during therapy. Bone marrow and tumor activity will be monitored using a sequence of FLT PET scans during the course of chemotherapy and radiation therapy.

Detailed description: Subjects will undergo a total of 5 FLT PET scans.
  Group 1 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 15 radiation treatments, and then 1 month after completing radiation therapy.
  Group 2 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 20 radiation treatments, and then 1 month after completing radiation therapy.

Eligibility: Inclusion Criteria:
  -  Ability to understand and willingness to sign a written informed consent document.
  -  Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of the cervix.
  -  Scheduled to receive chemo-radiation for oncologic treatment.
  -  Karnofsky of at least 60 at time of screening
  -  Life expectancy of at least 6 months.
  -  Leukocytes at least 3,000/microL
  -  absolute neutrophil count at least 1,500/microL
  -  platelets at least 100,000/microL
  -  total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal)
  -  either ALT or AST less than 2.5 times the upper limit of normal
  -  creatinine less than 1.5 times the upper limit of normal
  -  non-pregnant, non-nursing, willing to use contraception
  Exclusion Criteria:
  -  oncology research protocol requiring full pelvic radiation (i.e., 4-field box technique) or experimental chemotherapy
  -  uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
  -  subjects taking nucleoside analog medications such as those used as antiretroviral agents.
  -  patients who have undergone hysterectomy or will have a hysterectomy as part of their cancer therapy.

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

Clinical trial: A Study of MK1775 in Combination With Topotecan/Cisplatin in Patients With Cervical Cancer (1775-008)

Summary: This study will be conducted in two parts. Part 1 will determine whether administration of MK1775 in combination with topotecan and cisplatin is generally well-tolerated and causes clinical objective responses in patients with cervical cancer. Part 1 will also define the recommended Phase 2 dose and maximum tolerated dose (MTD) of the combination of MK1775 with topotecan and cisplatin. Part 2 of the study will evaluate whether treatment with MK1775 in combination with topotecan and cisplatin causes an improvement in progression-free survival (PFS) compared to treatment with topotecan and cisplatin alone and will further evaluate the tolerability of the combination treatment.


Eligibility: Inclusion Criteria:
  -  Patient has advanced, metastatic, and recurrent squamous cell, adenosquamous, or adeno-carcinoma of the uterine cervix (Stage II - IVb)
  -  Patient has received cisplatin in combination with radiation as initial or adjuvant treatment for their cervical cancer
  -  Patient has not received any other treatment for their cancer following the cisplatin-based chemo-radiation or targeted therapy except non-cytotoxic targeted therapy
  -  Recurrence must be at least 6 months post cisplatin-based chemotherapy
  -  Patient has measurable disease
  -  Patient's performance status on the Eastern Cooperative Oncology Group (ECOG) Performance Scale is less than or equal to 1
  -  Patient has a negative pregnancy test within 72 hours of the first dose of study medication
  Exclusion Criteria:
  -  Patient has had chemotherapy, radiotherapy, or biological therapy within 6 months of entering the study
  -  Patient has a history of vascular thrombotic events or vascular reconstruction
  -  Patient has active central nervous system (CNS) metastases and/or carcinomatous meningitis
  -  Patient has a primary CNS tumor
  -  Patient requires the use of medications or products that are metabolized by, or inhibit or induce CYP3A4 (Cytochrome P450 3A4)
  -  Patient is expecting to reproduce within the duration of the study or is pregnant or breastfeeding
  -  Patient is known to be Human Immunodeficiency Virus (HIV)-positive
  -  Patient has known active Hepatitis B or C
  -  Patient has a known history of interstitial lung disease or pulmonary fibrosis
  -  Patient has symptomatic ascites or pleural effusion
  -  Patient has a clinical history suggestive of Li-Fraumeni Syndrome

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

Clinical trial: GARDASIL™ Vaccine Impact in Population Study (V501-033)

Summary: This study will assess the impact of GARDASIL™ human papillomavirus (HPV) vaccine in the general female population by utilizing nationwide registry databases in the participating Nordic countries.

Detailed description: Time perspective: The study will be conducted using data collected both retrospectively/concurrently from registries and prospectively by questionnaire survey.
  Baseline survey data were collected during a prior study from 2004-2005.
  Safety Monitoring: An expert panel on teratology consisting of one teratologist from each of the participating countries will review all available medical records related to any congenital anomalies to search for any emerging patterns that may be indicative of an association between GARDASIL™ exposure in the mother and the subsequent congenital anomalies in the babies.

Eligibility: Inclusion Criteria: - Registry Data: * Female residents of participating Nordic countries who were alive on January 1st in the year the data will be used for analysis - Survey Data: --Female residents alive in the participating countries on July 1, 2011 --Women must provide consent to use questionnaire data and to link data to other registry databases - Cervical Sample Collection: --For HPV data in the general population: cervical samples from residents of the participating countries who are 45 years and under collected between 2006 and 2007, or in 2011-2012 --For HPV data in lesional samples: cervical samples from women with a diagnosis of CIN or cervical cancer between 2004-2006 and 2011-2012 Exclusion Criteria: - Registry Data: * Women who participated in Protocol V501-015 (NCT00092534) and are included in the Long-Term Follow-Up study - Survey Data: --Women under 18 or above age 45 on July 1, 2011 --Women who participated in Protocol V501-015 and are included in the Long-Term Follow-Up study - Cervical Sample Collection: --Samples from women who participated in Protocol V501-015 and are included in the Long-Term Follow-Up study --Samples with inadequate integrity for HPV testing

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

Clinical trial: Imaging the Uterine Cervix - UltraSightHD™

Summary: The purpose of this study is to investigate the performance ability of the UltraSightHD™. The instrument will be assessed on characteristics such as focus quality, ability to image the entire cervix, and illumination. The information gathered from this study will provide data that will be used to determine which settings provide the best imaging outcome for the cervix for a simple screening instrument. Further, this information will serve as the foundation in the development of more advanced follow-on imaging devices.
  The primary objectives of this study are to:
  -  Determine if the light source provides sufficient illumination of the cervix.
  -  Assess focus and overall image quality.
  -  Assess the functionality and ergonomics of the instrument's design.


Eligibility: Inclusion Criteria:
  -  Healthy Female
  -  18 years old or older
  -  Not pregnant
  -  Ability to give consent
  Exclusion Criteria:
  -  Male
  -  Less than 18 years old
  -  Pregnant or suspected pregnancy

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

Clinical trial: Self-collected Swabs for HPV Testing in 18-24 Year Old Women

Summary: The purpose of this study is to compare methods for transporting self-collected swabs for HPV testing in 18-24 year old women and to look at risk factors for HPV infection in 18-24 year old women.

Detailed description: We propose a cross-sectional study among 150 women in the United States who have used Internet dating sites in the past year in order to examine risk factors for high-risk HPV infections in 18-24 year old online daters, and evaluate strategies for transporting and storing self-collected samples for HPV testing. We will ask participants to complete a written questionnaire on their health, sexual behavior, and attitudes toward self-collecting vaginal swabs, HPV vaccination, and cervical cancer screening. Also, we will ask the women to self-collect two sequential vaginal swab samples that will be transported and stored according to the two strategies described above. Each sample will be tested for type-specific HPV DNA using a PCR-based assay.

Eligibility: Inclusion Criteria:
  -  Have had sex with men
  -  Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website)
  Exclusion Criteria:
  -  Pregnant or breastfeeding

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

Clinical trial: Pancreatic Cancer Genetics

Summary: The aim of this study is to determine the frequency of the three most common BRCA1 and BRCA2 genetic mutations that are commonly found in Ashkenazi Jewish patients with pancreatic cancer. Testing for BRCA1 and BRCA2 mutations in relatives of hereditary pancreatic cancer patients may have a significant impact; allowing for early screening, treatment, and resection of pre-malignant tissue or malignant lesions.

Detailed description: Pancreatic cancer is the fourth leading cause of death from malignancy in the United States. Up to 15% of pancreatic cancers have a hereditary component. Several gene mutations and cancer syndromes have been identified that are frequently found in greater frequency in individuals with pancreatic cancer, including the breast ovary cancer syndrome (BRCA1/BRCA2 mutations). No studies adequately describe the epidemiology of inherited pancreatic cancer and genetic risk factors that may modify the penetrance of BRCA1/BRCA2 mutations. The primary aim of this study is to determine the frequency of BRCA1 (185delAG,5382insC) and BRCA2 (6174delT) mutations in Ashkenazi Jewish pancreatic cancer patients. Secondary endpoints will include determining the individual frequency of these mutations and other disease-modifying mutations, death from any cause, disease-free survival, and stage of disease at time of presentation, differences in tissue pathology, risk factors, treatment decisions and development of metachronous malignancies.
  The investigator plan to study about 100 patients, which will enable the true frequency of the mutation to be estimated. Although the impact of BRCA1/BRCA2 mutations will be initially studied in the Ashkenazi population, these data will be widely applicable to other pancreatic cancer patients carrying BRCA1/BRCA2 mutations. Testing for BRCA1 and BRCA2 mutations in relatives of hereditary pancreatic cancer patients may allow early screening, treatment, and resection of pre-malignant tissue or malignant lesions.

Eligibility: Inclusion Criteria:
  -  Patients diagnosed with pancreatic cancer.
  -  Patients are of Ashkenazi Jewish descent.
  -  Patients have been Columbia Pancreatic Cancer Prevention Program Registry and Tissue Bank for High-Risk Individuals (IRB-AAAA6154).
  Exclusion Criteria:
  -  Inability to provide informed consent.
  -  Under the age of 18 years old.

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

Clinical trial: An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+

Summary: Cervical cancer is associated with Human Papilloma Virus. About 57% of cervical cancer is the result of infection by Human Papilloma Virus strain 16 (HPV-16). HPV is a very common virus that can affect the cells of the cervix. E7 is a substance that is made by the HPV virus which causes cervical cancer. The purpose of the study is to test the safety, tolerability (how the drug makes you feel), immunology (effects on the immune system) and efficacy (disease curing effects) of a vaccine called Lovaxin C against E7. The vaccine is designed to cause the immune system to react against the E7 substance in a manner that is intended to reverse the changes to the cervix and prevent cervical cancer from occurring.

Detailed description: Worldwide, many women carry HPV and cervical cancer is the leading cancer killer of women under the age of 50. Although its consequences are considerably less severe in the US, it leads to considerable morbidity. Many published clinical trials describe the immunotherapeutic treatment of early stage, pre-invasive, cervical cancer. It is widely recognized that immunotherapies are most effective in early stage disease because the immune system is least debilitated and disease burden is lowest. Invasive cervical cancer is preceded by a long, slowly progressive, pre-invasive phase termed Cervical Intraepithelial Neoplasia (CIN), which allows for this therapeutic approach. An ideal therapy would result in the remission of CIN 2/3 without damage to cervical tissue. A National Institute of Cancer panel charged with achieving consensus on this issue concluded that a non-surgical medical treatment for this indication would be valuable
  The primary objectives of this trial are to test three doses of Lovaxin C to determine if vaccination with Lovaxin C in women with CIN 2/3 for whom surgery is indicated can safely reverse the disease compared to placebo treated control patients.
  An earlier Phase 1/2 trial of Lovaxin-C in late stage metastatic cervical cancer used a regimen of two doses given with a 28-day interval. That regimen was shown to be safe and to generate reduction in tumor burdens in some patients. In this trial we will treat earlier stage disease in healthier patients with better immune systems, will use the same and lower doses as given before, but add an additional dosing to the regimen by administering the lowest dose that we assessed previously and by adding a third vaccination to the prior regimen. Unlike the phase 1 trial in which 2 doses were given with a 3 week separation, dosing in the proposed trial will be separated by 4-week intervals.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed CIN 2/3 that requires surgical intervention
  Exclusion Criteria:
  -  Previous history of listeriosis
  -  Steroid use
  -  Antibiotic use
  -  Negative anergy panel
  -  HIV positive
  -  Pregnant or actively trying during the treatment period
  -  Intercurrent disease

Relevance to patient case: not relevant