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

Clinical trial: Tomotherapy in Postsurgery Recurrent Carcinoma Cervix

Summary: Radiotherapy is the most appropriate treatment for postoperative recurrent carcinoma cervix. However it is technically difficult to deliver adequate doses of RT due to presence of small intestines in the radiation area; thus disease control rates are poor and complication rates are high with conventional radiotherapy. Use of IMRT and brachytherapy for these cases allows for increasing dose to the tumor while sparing normal structures. It is expected that the use of a combination of IMRT & brachytherapy will achieve higher disease control rates and decrease the complication rates.

Detailed description: SPECIFIC OBJECTIVES:
  1. To evaluate the efficacy of combination of intensity-modulated radiotherapy (IMRT) and brachytherapy in delivering dose escalated radiotherapy in postoperative residual / recurrent cases of carcinoma cervix, in terms of local control proportion and progression free survival (PFS)
  2. To study the late and acute toxicities associated with this treatment.
  3. Dosimetric comparison of Tomotherapy and conventional IMRT
  DESIGN: Prospective, phase II study.
  STUDY POPULATION: All patients of age < 65 years diagnosed with postsurgery recurrent squamous cell carcinoma cervix without previous history of radiotherapy.
  STUDY SIZE: 90 patients
  METHODOLOGY: Ninety cases of cervical cancer with postsurgery recurrence limited to the pelvis will be screened and taken for study if eligible after taking the informed consent.
  Patients will receive external radiation therapy using IMRT to pelvis with additional dose of localized radiotherapy boost with brachytherapy to the vault with weekly concurrent chemotherapy.
  The local recurrence rate and 5 year disease free survival rate of all the patients will be studied.
  PROJECT PERIOD:
  Total project period : 5 years Recruitment, Data collection : 4 years Complete analysis of data : 1 year
  STUDY SITE: Tata memorial centre

Eligibility: Inclusion Criteria:
  . Only histologically proven postoperative recurrence of squamous carcinoma of cervix following hysterectomy >3 months without adjuvant treatment
  -  Patients below 65 years of age and with KPS >70%.
  -  Patients with disease confined to the pelvis, based on CT/MRI/PET Scan
  -  Normal ECG and cardiovascular system
  -  Normal hematological parameters
  -  Normal renal and liver function tests
  Exclusion Criteria:
  -  Previous chemotherapy or radiotherapy to the pelvis
  -  Pelvic LN >3cm in size
  -  Presence of disease outside the pelvis (Paraortic nodes, distant metastasis)
  -  Bilateral hydronephrosis
  -  Co-morbid conditions like uncontrolled Diabetes Mellitus or medical renal disease
  -  Medical or Psychological condition that would preclude treatment
  -  Patient unreliable for treatment and follow-up.

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

Clinical trial: Burden of Cervical Cancer in Tanzania

Summary: Cervical cancer screening is a worldwide problem especially in the developing world of which Tanzania belongs. It is diagnosed late in the third world because there are no diagnostic facilities and resource people. It occurs in the age groups between 40 and above and therefore affects the productive age of the community. It is well known that women generally are the backbone of every community and specifically in the developing countries.
  The objective of this research is to analyze and quantify the burden of cervical cancer disease in the community. It will research the interpersonal and socioeconomic issues associated with cervical cancer disease in the family.


Eligibility: Inclusion Criteria:
  -  new pathological diagnosis of cervical cancer
  Exclusion Criteria:
  -  non consenting individuals

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 Everolimus in the Treatment of Advanced Malignancies in Patients With Peutz-Jeghers Syndrome

Summary: In this pilot study the investigators will treat all patients known with Peutz-Jeghers syndrome (PJS) who are diagnosed with advanced malignancies with everolimus 10mg daily until disease progression. Most patients with PJS have an inherited LKB1 mutation leading to aberrant m-TOR activity. Their risk to develop malignancies or intestinal polyps is probably related to this constitutive mTOR signaling. The hypothesis is that mTOR inhibition is an effective anticancer treatment in PJS patients with advanced malignancies.


Eligibility: Tow cohorts of PJS patients will be included. Cohort 1: Advanced malignancy Cohort 2: High risk polyps
  General inclusion criteria:
  1. Known Peutz-Jeghers disease (with LKB1 mutation)
  2. No concurrent systemic anti cancer treatment
  3. No prior treatment with m-TOR inhibitor
  4. Prior malignancies or concurrent second malignancies are allowed
  5. Prior systemic therapy is permitted with a washout time of at least 4 weeks
  6. ECOG/ WHO performance 0-2
  7. Age > 18 years
  8. Adequate renal function (defined as creatinine < 150 μmol/L)
  9. Adequate liver function (bilirubin < 1.5 times upper limit of normal, ALAT or ASAT < 5.0 times upper limit of normal in case of liver metastases and < 2.5 the upper limit of normal in absence of liver metastases
  10. Adequate bone marrow function (WBC > 3.0 x 10 9/L, platelets > 100 x 10 9/L)
  11. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
  12. No pregnancy or lactating and ifof childbearing potential patients must agree to use a reliable contraceptive method throughout the study
  13. No serious concomitant systemic disorder that would compromise the safety of the patient,at the discretion of the investigator
  14. Signed informed consent according to ICH/GCP.
  15. No uncontrolled symptomatic hyperglycaemia
  Specific inclusion criteria for cohort 1:
  1. Cytological or histological confirmed carcinoma
  2. Metastatic or non-resectable disease
  3. Patients with clinically and/or radiographically documented measurable lesion according to
  RECIST criteria:
  1. X-ray, physical exam > 20 mm
  2. Spiral CT scan > 10 mm
  3. Non-spiral CT scan > 20 mm
  Specific inclusion criteria for cohort 2:
  1. Known high risk polyps (definition see page 19)
  2. Ability to undergo endoscopies
  Specific Exclusion criteria:
  Symptomatic PJ-polyps, defined as polyps likely to be responsible/causal for the abdominal symptoms the patient presents with.

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

Clinical trial: Predictive Assays In Cervix Cancer

Summary: The experiments outlined in this proposal will compare a number of currently available techniques for assessing hypoxia and interstitial fluid pressures in patients with cervix cancer. The aim of these experiments is to establish the relationship of the clinically relevant outcome measures of tumour control and survival following radiation therapy with these biological characteristics of carcinoma of the cervix relevant to tumour hypoxia. These characteristics will be assessed in patients undergoing treatment using techniques which have reached an appropriate level of development for clinical evaluation and aim to determine the best technique for determining these parameters of the tumour microenvironment. A number of novel strategies directed at the microenvironment are undergoing or soon will be undergoing clinical evaluation and selection of appropriate patients for these trials is of great importance.


Eligibility: Inclusion Criteria:
  1. Histologic diagnosis of cervix cancer
  2. A decision to treat using radiation therapy according to the existing treatment policies of the PMH Gynecology Group
  3. Clinical stage IB-IV with grossly evident cervical disease
  4. No distant metastases
  5. No cytotoxic anti-cancer therapy for cervical carcinoma prior to study entry
  6. Signed informed consent
  Exclusion Criteria:

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

Clinical trial: The Effect of East-West Collaborative Medicine on Chronic Cervical Pain

Summary: The purpose of this study is to assess the effect of East-West collaborative medicine on chronic cervical pain.

Detailed description: Design: This is a randomized, controlled study.
  Participants: 45 participants with chronic cervical pain are recruited and randomly assigned to three groups.
  Intervention: Over an three-week period, one group(n=15) gets western medicine treatment(drug medication); another group(n=15) gets oriental medicine treatment(individualized needling 2-3 times a week); the other group(n=15) gets western medicine plus oriental medicine treatment for 3 weeks

Eligibility: Inclusion Criteria:
  - presence of Chronic neck pain
  Exclusion Criteria:
  -  Cancer
  -  Spinal infection
  -  ankylosing spondylosis
  -  myelopathy
  -  moderate hypertension or more
  -  serious mental disease
  -  other skeletomuscular disease
  -  history of operation or acupuncture treatment about spinal disease

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

Clinical trial: Cross-sectional Study on Human Papillomavirus Type Distribution in Adult Women Diagnosed With Cervical Cancer

Summary: The current study will elucidate the human papillomavirus type distribution in a population of women diagnosed with cervical high grade pre-cancerous lesions and invasive cervical cancer in Sri Lanka.


Eligibility: Inclusion Criteria:
  -  A female > 21 years of age at the time of diagnosis of invasive cervical cancer or cervical intraepithelial neoplasia - moderate or severe.
  -  Histologically confirmed diagnosis of cervix intraepithelial neoplasia - moderate or severe, invasive cervical cancer, glandular lesions and other epithelial tumours.
  -  Written informed consent obtained from the subject prior to study start.
  -  Subjects who the investigator believes can and will comply with the requirements of the protocol, should be enrolled in the study.
  Exclusion Criteria:
  -  Previous vaccination against human papillomavirus.
  -  History of chemotherapy or radiotherapy for cervical cancer.
  -  Subjects with recurrent episodes of invasive cervical cancer or cervical intraepithelial neoplasia- moderate or severe.

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

Clinical trial: Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence

Summary: Uterine cervical cancer is the second most common female malignancy. Therapy monitoring is essential to detect early recurrence. Diffusion-weighted magnetic resonance imaging is an emerging MRI imaging technique which has a potential value for the detection of primary and recurrent disease and for the assessment of response to therapy. The purpose of this project is to evaluate the predictive value of DWI during and after therapy in the prediction of recurrence of cervical uterine cancer. It will be considered whether DWI is able to provide early information about the response to therapy. This could enable the identification of less- or non-responsive tumors and in this way therapy can be adapted as soon as possible. Hence the investigators could offer the patient a more efficient treatment scheme and a reduction in toxicity related to the treatment could be established.


Eligibility: Inclusion Criteria:
  -  Patients diagnosed with cervical uterine cancer are, on a voluntary basis, enrolled in the study. These are patients who either underwent curative chemoradiation (mainly patients with advanced stage cancer) or neoadjuvant chemotherapy (predominantly in patients with early stage cancer) before undergoing surgery.
  Exclusion Criteria:
  -  Patients with known contra-indications for MRI (cardiac pacemakers, cochlear implants, claustrophobic patients) will be excluded from this study. And so are patients with contra-indications to Gadolinium-based contrast agents and patients with a known restricted renal function (GFR < 30 ml/min).

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

Clinical trial: Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced Cervical Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving cisplatin together with radiation therapy may kill more tumor cells.
  PURPOSE: This phase I/II trial is studying the side effects and best dose of cisplatin given together with radiation therapy in treating patients with locally advanced cervical cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To determine the feasibility of dose-escalation of chemoradiotherapy comprising cisplatin in combination with simultaneous-boost intensity-modulated radiotherapy (IMRT) in patients with locally advanced cervical cancer.
  Secondary
  -  To assess the objective response rates in patients treated with this regimen.
  -  To assess the local control of the disease in patients treated with this regimen.
  -  To correlate toxicity with dose-volume histogram data in these patients.
  OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II study.
  Patients receive cisplatin IV over 1 hour weekly for up to 5 weeks. Patients also undergo intensity-modulated radiotherapy 5 days a week for approximately 6 weeks.
  Patients complete a quality-of-life questionnaire at baseline, during, and after completion of study therapy.
  After completion of study treatment, patients are followed up at 4 and 12 weeks, every 3 months for 2 years, and then periodically for 5 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed squamous cell carcinoma, adenocarcinoma, or poorly differentiated carcinoma of the cervix
  -  Locally advanced disease
  -  FIGO stage IIB-IVA (any pelvic nodal status) or FIGO stage IB2 and IIA (with pelvic nodal involvement)
  -  Measurable disease on MRI scan
  -  No evidence of common iliac or para-aortic nodal involvement
  -  No distant metastases
  PATIENT CHARACTERISTICS:
  -  WHO performance status 0-1
  -  Platelet count > 100 x 10^9/L
  -  White cell count > 3.0 x 10^9/L
  -  Neutrophil count > 1.5 x 10^9/L
  -  ALT/AST < 2.5 times upper limit of normal (ULN)
  -  Bilirubin < 1.25 times ULN
  -  EDTA clearance > 55 mL/min
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No prior cancer except skin tumor
  -  No prior pelvic adhesions, inflammatory bowel disease, pelvic inflammatory disease, or diabetes mellitus
  PRIOR CONCURRENT THERAPY:
  -  No prior pelvic radiotherapy or surgery other than laparoscopic node dissection
  -  No other concurrent anticancer or investigational therapy

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

Clinical trial: Metformin in High Responder Polycystic Ovary Syndrome (PCOS) Patients Undergoing IVF Cycles

Summary: The use of metformin pre-treatment and co-administration was recently proposed in infertile women affected by polycystic ovary syndrome (PCOS) treated with gonadotropins.
  Data from meta-analyses showed that metformin administration significantly reduced the stimulation length and the total dose of gonadotropins used in PCOS women undergoing gonadotropins stimulation for non in-vitro fertilization (IVF) cycles. On the other hand, in IVF cycles metformin was demonstrated to significantly reduce the ovarian hyperstimulation syndrome (OHSS) rate in infertile patients with PCOS treated with gonadotropins.
  The metformin regulating effect on the ovarian response was also observed in a randomized controlled trial (RCT) on young non-obese insulin-resistant women with PCOS receiving gonadotropins for mono-ovulation induction. In particular, metformin increased the mono-ovulatory cycles, the duration of stimulation and the amount of gonadotropins used, while it reduced the number of dominant follicles and the estradiol (E2) levels.
  The aim of the present study was to evaluate the effect of metformin administration in high responder PCOS patients undergoing gonadotropins ovarian stimulation for IVF cycles.

Detailed description: Infertile young non-obese insulin-resistant patients with PCOS who had a background of the first IVF treatment cycle cancelled because of high risk for OHSS will be enrolled and randomized in two treatment arms.
  In their second IVF attempt, the experimental group will receive metformin (500 mg, 3 times daily) pre-treatment for two weeks and co-administration during gonadotropins ovarian stimulation; the control group will be treated with placebo (2 cps daily) pre-treatment and co-administration by using the same schedule of the experimental group. In all patients, ovarian stimulation will be carried out with a personalized step-down gonadotropin in association with a minidose flare-up GnRH agonist protocol.

Eligibility: Inclusion Criteria:
  -  History of one previous cancelled cycle for high-risk of OHSS, or history of moderate/severe OHSS during their previous IVF cycle
  -  Infertility
  -  Polycystic ovary syndrome (PCOS)
  -  insulin resistance
  -  hyperandrogenism
  Exclusion Criteria:
  -  BMI>30 kg/m2
  -  age >35 years
  -  FSH>9UI/L

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

Clinical trial: SUV Max as Predictor of Outcome in Cervical Cancer

Summary: Cervical Cancer is staged clinically, not surgically. Patients in whom an extensive disease is identified are not usually eligible for surgery. PET-CT is used to support staging. However, some patients received surgery after staging and subsequently require radio/chemotherapy due to findings on operation.
  This study will attempt to find a correlation between SUV-Max on PET-CT and subsequent outcomes i.e. need for adjuvant therapy.


Eligibility: Inclusion Criteria:
  -  having stating PET-CT stored on site
  -  treated with surgery
  Exclusion Criteria:
  -  not eligible for surgery based on PET-CT, clinical stage

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

Clinical trial: Human Papillomavirus (HPV) Type Distribution in Adult Women Diagnosed With Invasive Cervical Cancer in New Zealand

Summary: The aim of this study is to assess the distribution of the most frequent types of human papillomavirus in women diagnosed with invasive cervical cancer in New Zealand.


Eligibility: Inclusion Criteria:
  -  A female aged 18 years and above at the time of cervical specimen collection, and currently residing in New Zealand.
  -  Histological diagnoses of invasive cervical cancer stage IB or greater, within at least the last 3 years.
  -  Written informed consent obtained from the subject/ next of kin/ Legally acceptable representative.
  -  Availability of cervical specimen on which the diagnosis was made prior to any chemotherapy or radiotherapy.
  -  The cervical specimen should be of appropriate size and with regular tissue specimens.
  -  The cervical specimen should be adequately preserved.
  -  All links to the subject's identity should be removed from the paraffin block.
  Exclusion Criteria:

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

Clinical trial: Serum IGF-II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer

Summary: The purpose of this study is to determine whether Insulin-like Growth Factor II is elevated sufficiently to detect Cervical Intraepithelial Neoplasia II (CIN II), Cervical Intraepithelial Neoplasia III (CIN III), and cervical cancer.


Eligibility: Inclusion Criteria:
  -  Age 18 - 75 years
  -  Female
  -  Normal medical history
  -  Medical history of a single type of cancer confirmed by biopsy or equivalent criteria
  -  Squamous cell carcinoma of organs other than cervix
  -  Adenocarcinoma
  -  Medical history of inflammatory disease
  -  May be pregnant
  -  Pap smear positive for Cervical Intraepithelial Neoplasia II or III
  -  Squamous cell cervical cancer confirmed by biopsy
  -  Informed consent
  -  Willingness to submit a blood sample by venipuncture
  -  Willingness to submit a second blood sample if necessary
  Exclusion Criteria:
  -  Age < 18 or > 75 years
  -  Medical history of cancer other than cervical cancer, Non-islet-cell tumor hypoglycemia, Growth hormone deficiency, Acromegaly, Hepatoma, inflammatory disease in addition to confirmed CIN and cervical cancer

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

Clinical trial: Distribution of Human Papillomavirus (HPV) Genotypes in Patients With Cervical Cancer From Croatia

Summary: Human papillomavirus (HPV) of high-risk genotype is a necessary risk factor in development of cervical cancer. There is a vaccine available to prevent cervical lesions associated with high-risk HPV genotypes 16 and 18. In Croatia HPV vaccination has not yet been introduced in obligatory vaccination schedule. The aim of this study is to describe the pre-vaccination distribution of HPV genotypes in women with high grade cervical squamous intraepithelial lesion (HSIL) and cervical cancer in Croatia. The investigators hypothesis is that HPV-16 is the most frequently found genotype but the distribution of other HPV genotypes is heterogeneous and includes genotypes currently not covered by vaccination.

Detailed description: This is a single-center cross-sectional study on the molecular virology of human papillomavirus (HPV) in Croatia. The study will enroll women aged 18-65 years of age with cervical intraepithelial neoplasia (CIN2+)cervical lesions that received clinical care at the Croatian Center for Pre-malignant and Malignant Diseases of the Cervix. Women with abnormal cytology (high grade cervical squamous intraepithelial lesion-HSIL, cervical cancer) in the period from 2010 to 2012 will be included. Relevant epidemiological and clinical data will be collected. Biological samples will include both biopsy specimens from cervix and cervical swab. Biological samples will be put in Digene Specimen Transport Medium (Qiagen, Gaithersburg, MD) and further analyzed at the Department of Molecular Diagnostics at the University Hospital for Infectious Diseases in Zagreb. HPV genotyping will be performed by using a standardized molecular assay INNO-LiPA HPV Genotyping Extra Test (Solvay S.A., Brussels, Belgium). Analysis of genomic variants of HPV 16 genotype will be performed by population-based sequencing of L1 genome region.

Eligibility: Inclusion Criteria:
  -  Women aged 18-65 with a cytological diagnosis of CIN2+cervical lesions from all over Croatia that are referred to National Reference Center because of HSIL or malignant cytology findings
  Exclusion Criteria:
  -  Women younger than 18 or older than 65
  -  Pregnant women

Relevance to patient case: not relevant