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

Clinical trial: Improving Tumor Oxygenation in Cervical Cancer

Summary: The Phenomenon of Tumor Hypoxia Many solid tumors are relatively resistant to treatment with ionizing radiation and certain chemotherapeutic agents such as anthracyclines that are affected adversely by acidic pH. These effects have primarily been attributed to the presence of hypoxic cells within the tumor. The relevance of hypoxia with respect to failure of radiotherapy to cure certain malignancies has had a chequered history. However, in recent years the evidence that hypoxia plays a central role in relative radioresistance has become more compelling.
  Since approximately two-thirds of all women suffering from cervical carcinoma receive radiation as a component of their therapy, an enhanced understanding of the interactions between hypoxia and radiation as a component of their therapy, an enhanced understanding of the interactions between hypoxia and radiation resistance is critical to improving outcome among those with cervical cancer.


Eligibility: Inclusion Criteria:
  -  The subject will have a malignant tumor of the cervix which is not curable by surgery in which it has been determined the subject is to receive the standard care of treatment of radiation therapy and chemotherapy.
  -  The subject must have adequate bone marrow function, renal function, hepatic function and neurologic function.
  -  The subject should be free of active infection requiring antibiotics.
  -  The subject must have signed the approved informed consent
  -  If the subject is of childbearing age, they must have a negative urine pregnancy test with effective contraception
  -  The subject must have met pre-entry requirements
  1. Physical examination to include pelvic examination, blood counts, assessment of liver and kidney status through blood studies
  2. A serum pregnancy test
  3. Detectable tumor will be measured.
  Exclusion Criteria:
  -  The subject has not been clinically staged for their cancer
  -  The subject has evidence of or is being treated for an active infection
  -  The subject cannot perform the appropriate follow-up or complete the study for whatever reason.
  -  The subject has not consented to an additional tumor biopsy and MRI after my seven days of treatment with methazolamide
  -  The subject has evidence of chronic obstructive pulmonary disease
  -  The subject is currently breastfeeding
  -  The subject is pregnant
  -  The subject takes aspirin chronically
  -  The subject has a history of Stevens-Johnson syndrome
  -  The subject has not signed the approved 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: Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)

Summary: This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.


Eligibility: Inclusion Criteria:
  -  Lifetime history of 0-4 sexual partners
  Exclusion Criteria:
  -  History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test

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

Clinical trial: Young Women's Breast Cancer Research Program

Summary: The purpose of this study is to identify novel genetic factors which distinguish breast cancer in younger women compared to older women. By identifying these novel genetic factors we believe more specific therapies can be developed and breast cancer may be prevented among women with an increased cancer risk. A woman does not have to live in St. Louis to participate.

Detailed description: Breast cancer takes its greatest toll on younger women, as it is the leading category of cancer deaths for women 20-39 years of age. Sadly, survival rates are lowest among women diagnosed at a young age. This impact is most significant among African-American women who have the highest incidence and mortality rate among women less than 45 years of age. The goal of our program is to identify the genetic factors which distinguish breast cancer in younger women compared to older women.
  Women who were diagnosed with invasive breast cancer 40 years of age or younger are invited to participate. The age at diagnosis is used to determine eligibility, not a woman's current age. Women who have undergone genetic testing of the BRCA1, BRCA2, p53, pTEN, e-cadherin, or LKB1 genes are eligible to participate. Young women with breast cancer are asked to: sign a consent form, submit a sample of blood, release their cancer related records, and answer some family history questions.
  We will use a family based case control approach in our analysis. As such, if a woman's parents are living, they will be invited to participate as a "comparison" group. The parents are asked to: sign a consent form, submit a sample of blood, and release any cancer records.
  A woman does not have to live in St. Louis to participate. All study related materials can be mailed directly to the young woman or her parents. There is no expense to the family. All materials are kept strictly confidential and participation is completely voluntary.

Eligibility: Inclusion Criteria:
  -  Women diagnosed with invasive breast cancer 40 years of age or younger. If their parents are living, the parents are also invited to participate, regardless of their history of cancer.
  Exclusion Criteria:
  -  Women diagnosed with in-situ breast cancer.

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

Clinical trial: Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer

Summary: A Phase I Study of Adjuvant Topotecan and Cisplatin with Concurrent Radiation Therapy for Advanced Cervical Cancer.

Detailed description: Examines the effects of Topotecan and Cisplatin with radiation for advanced cervical cancer

Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed advanced cervical carcinoma who, following optional surgical staging, are not deemed to be curable by either surgery or radiotherapy alone. This includes patients with stages IIB, IIIA, IIIB or IVA and stages IB or IIA who in addition have one of the following risk factors:
  -  Primary tumor > 6 cm
  -  Positive pelvic and/or para-aortic lymph nodes (resected or unresected)
  -  Positive surgical margins
  -  Depth of invasion greater than 50 % and positive capillary-lymphatic space involvement
  -  Eligible cell types include squamous, adenosquamous and adenocarcinoma of the cervix
  -  Patients may have measurable disease (defined as lesions which can be measured in at least two (2) dimensions by physical examination or any medical imaging technique). Inability to measure disease will not constitute exclusion criteria.
  -  Patients with GOG performance status of 0, 1, or 2.
  -  Patients will have recovered from the effects of recent surgery and should be free of clinically significant infection.
  -  Patients must have adequate:
  -  Bone marrow function: WBC greater than or equal to 3,000 cells/mm3, platelet count greater than or equal to 100,000 cells/mm3, and granulocyte count greater than or equal to 1,500 cells/mm3.
  -  Renal function: Creatinine less than or equal to 2.0 mg/dl.
  -  Hepatic function: Bilirubin less than or equal to 1.5 x institutional normal, SGOT and alkaline phosphatase less than or equal to 3 x institutional normal.
  -  Patients must have signed an approved informed consent.
  -  Patients have met the pre-entry requirements specified in Section 7.0
  Exclusion Criteria:
  -  Patients with GOG performance of 3 or 4.
  -  Patients with another malignancy, prior or concomitant, other than skin (excluding melanoma).
  -  Patients with septicemia, severe infection, gastrointestinal bleeding, or intestinal obstruction.
  -  Patients with anatomic abnormalities requiring modification of radiation fields (pelvic kidney, renal transplant, etc.).
  -  Patient with recurrent cervical cancer
  -  Patients who have received prior pelvic radiation
  -  Pregnant women and women of childbearing potential not using an effective form of contraception.
  -  History of thrombus (10/28/02)
  -  History of unstable angina or MI within the past six months. Patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months. (10/28/02)

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

Clinical trial: Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study (V502-003)

Summary: This study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, and persistent infection caused by the HPV types in the study vaccine, (2) To demonstrate that the vaccine is well-tolerated in women, (3) To evaluate vaccine immune responses in women.
  This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility: Inclusion Criteria:
  -  Female, between the ages of 16 and 26
  Exclusion Criteria:
  -  History of an abnormal PAP test or abnormal cervical biopsy result
  -  History of external genital/vaginal warts
  -  History of positive HPV test
  -  Currently a user of any illegal drugs or an alcohol abuser
  -  Are pregnant
  -  Currently enrolled in another clinical trial
  -  Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent).

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

Clinical trial: Reducing Cancer Disparities for American Indians in the Rural Intermountain West

Summary: The purpose of this demonstration is to evaluate the effectiveness of using community outreach workers (navigators) to help American Indians living in rural areas overcome barriers to appropriate cancer screening, diagnosis, and treatment.

Detailed description: Even for American Indians who have coverage with Medicare, disparities have been noted in the provision of cancer screening, diagnosis, and treatment. These disparities have been related to a variety of health-system, health-financing, geographic, and cultural barriers. We hypothesize that the use of lay community outreach workers will be an effective means of identifying and overcoming these barriers in order to improve the proportion of Medicare-eligible American Indians who receive recommended screening and diagnosis for prostate, breast, colon, and cervical cancer, and the proportion of individuals receiving appropriate treatment for prostate, breast, colon, cervical, and lung cancer. Community clusters randomized to this form of cancer navigation will be compared with community clusters randomized to receive educational outreach only.

Eligibility: Inclusion Criteria:
  -  Enrolled in Medicare Part B
  -  Self-reported American Indian
  Exclusion Criteria:
  -  Have cancer other than study cancer
  -  Medicare Part C enrolled

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

Clinical trial: Improving Employment in Patients Who Have Survived Cervical Cancer, Uterine Cancer, or Ovarian Cancer

Summary: RATIONALE: Finding out which problems affect employment in survivors of gynecologic cancer may help in planning cancer treatment and improve the quality of life of future cancer survivors.
  PURPOSE: This research study is looking at ways to improve employment in patients who have survived cervical cancer, uterine cancer, or ovarian cancer.

Detailed description: OBJECTIVES:
  -  Conduct formative work, including 4 to 5 focus groups, leading to development of a structured interview instrument assessing factors related to employment outcomes among women with gynecologic cancers.
  -  Pilot a recruitment strategy and administer the interview among a sample of 60 to 70 gynecologic cancer survivors; and, with each woman's permission, a family member, a key health care provider, and her supervisor will be interviewed.
  OUTLINE: This is a multicenter, pilot study.
  Patients complete a survey, meet with a focus group, and undergo a short interview. Patient-designated participants are also interviewed; these individuals may include a health care provider, a significant other, and/or a work supervisor.
  PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following invasive cancers:
  -  Cervical cancer
  -  Uterine cancer
  -  Ovarian cancer
  -  Diagnosed ≥ 6 months ago
  -  Any stage disease
  -  Employed at the time of diagnosis, defined as working for pay ≥ 20 hours/week
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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

Clinical trial: Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer

Summary: The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy


Eligibility: Inclusion Criteria:
  -  Age between 18 and 70 years old
  -  Cervical uterine cancer (epidermoid or adenocarcinoma, stage:from IB> or = 4 cm to IV, according to FIGO classification) histologically proven
  -  Measurable lesions,clinically and by MRI assessed
  -  PS-WHO < or = 2 ou Karnofsky Index >70 per cent
  -  Life expectancy > 3 months
  -  Hematologic function: leukocytes < or = 3 G/l, polynuclear neutrophil leukocytes > or = 1.5 G/l, platelets > or = 100 G/l, hemoglobin > or = 10 g/dl
  -  Hepatic function: ASAT and ALAT < 2.5 ULN
  -  Renal function: creatininemia < 1.5 ULN, clearance > 60 ml/min
  -  No prior chemotherapy or radiotherapy
  -  Contraception
  -  Written informed consent signed
  Exclusion Criteria:
  -  Stage IB < 4 cm or IVB
  -  Other histology than epidermoid or adenocarcinoma
  -  Distant metastases, including sus-clavicular adenopathy
  -  Contraindication to MRI
  -  Pregnant or lactating woman
  -  Auto-immune disease
  -  Peripheric neuropathy, autograft or homograft, psychiatric disease
  -  Prior cancer (except cutaneous basocellular carcinoma and uterine cervical carcinoma in situ)
  -  Active infection
  -  Other clinical trial with an experimental drug
  -  Known positive serology (HIV, HbC, HbS)

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

Clinical trial: New Indications for Ultrasound in the Staging of Cervical Cancer

Summary: The purpose is to investigate and evaluate two new diagnostic methods using ultrasound in the staging of cervical cancer.
  1. 3-D-ultrasound of the tumour to estimate its volume and local spread
  2. Fusion of PET/CT and ultrasound to evaluate and biopsy lymph nodes.


Eligibility: Inclusion Criteria:
  -  Cervical cancer,
  -  PET/CT pos. lymph nodes,
  -  Patients over 18 years old
  Exclusion Criteria:
  -  Pregnancy,
  -  Lactating,
  -  Diabetic

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

Clinical trial: Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years

Summary: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will supplement an ongoing study evaluating the safety, efficacy and immunogenicity of the vaccine in women aged 26 years and above. This study will therefore assess additional immunogenicity parameters of the vaccine in women from selected investigative sites.
  The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility: Inclusion Criteria:
  -  A female enrolled in study 104820 and who received three doses of study vaccine/control.
  -  Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  -  Written informed consent obtained from the subject prior to enrolment in this ancillary study.
  Exclusion Criteria:
  -  Pregnancy.
  -  Administration of any HPV vaccine other than that foreseen by the study protocol.
  -  Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine since study start.
  -  Chronic administration of immunosuppressants or other immune-modifying drugs since study start.
  -  Administration of immunoglobulins and/or any blood products within 90 days preceding a blood sampling.

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

Clinical trial: Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer

Summary: RATIONALE: Finding certain changes in genes may help doctors predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may help the study of cancer in the future.
  PURPOSE: This clinical trial is studying genes that may predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer.

Detailed description: OBJECTIVES:
  -  Utilize molecular assays to identify a panel of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer (ICC) among patients with or without HIV infection.
  -  Perform a nested case-control study assessing the risk of developing CIN3 in relationship to human papillomavirus (HPV) persistence, HIV, and the presence or acquisition of candidate hypermethylated genes in these patients.
  -  Identify HIV-related factors (e.g., CD4 counts, viral load, and highly active antiretroviral therapy [HAART]) that might be associated with the presence or acquisition of specific hypermethylated genes in these patients.
  OUTLINE: This is a longitudinal, multicenter study.
  Patients undergo biopsy for removal of cervical tissue. Patients also undergo blood and urine sample collection. Samples are analyzed for the presence of cancer or changes that indicate that cancer might develop. Patients also undergo colposcopy at baseline and at 3 years.
  After completion of study procedures, patients are followed every 4 months for up to 3 years.
  PROJECTED ACCRUAL: A total of 1,150 patients will be accrued for this study.

Eligibility: INCLUSION CRITERIA:
  -  Underwent Pap smear, human papillomavirus (HPV) testing, and HIV testing AND meets any of the following criteria:
  -  Biopsy and colposcopy confirmed cervical intraepithelial neoplasia (CIN) or invasive cervical cancer (ICC), meeting any of the following criteria:
  -  CIN grade 2-3 or higher
  -  Repeated CIN1 (times 6)
  -  Abnormal Pap smear (atypical squamous cells of undetermined significance [ASCUS] or worse)
  -  HIV seropositive
  -  Negative cytology but positive for high-risk human papillomavirus (HPV)
  -  Negative cytology and negative HPV
  -  HIV negative (without biopsy-proven CIN 3 or worse) and high-risk HPV infection (types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 68, 82, 83, 73)
  -  >= 18 years of age
  -  Intact cervix
  -  Not pregnant
  -  Able to provide informed consent
  EXCLUSION CRITERIA:
  -  < 18 years of age
  -  Pregnant at screening
  -  Cervix not intact
  -  not able to provide 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: Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening

Summary: Human papillomavirus (HPV)-based cervical screening is known to increase sensitivity for detection of high-grade cervical intraepithelial neoplasia (CIN). Randomized trials of longitudinal efficacy are required to assess whether these gains represent overdiagnosis or a protective effect.
  Methods: A total of 12527 women, aged 32-38, attending population-based invitational screening in Sweden were randomized 1:1 to HPV test and cytology (intervention arm) or cytology only (control arm). HPV-positive women were invited for a second HPV test at least one year later and women with type-specific persistent infections were then invited to colposcopy. A similar number of random double-blinded procedures are performed in the control arm. Women are followed with comprehensive registry-based follow-up. Primary outcome is the relative rates of CIN grade 2 or worse (CIN2/CIN3+) found in subsequent screening. Secondary outcomes are the relative rates of CIN2/CIN3+ found in the aseline screening and outcomes stratified by grade of CIN (CIN 2 or CIN3+).


Eligibility: Inclusion Criteria:
  -  Women aged 32-38 years old
  -  Attending the Swedish population-based organised cervical screening program
  Exclusion Criteria:
  -  Not providing informed consent

Relevance to patient case: not relevant