Neoplasms

All Conditions

Infections

Papilloma

Virus Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Micronutrients

All Drugs and Chemicals

Hematinics

Vitamins

Folic Acid

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Trace Elements

Folinic Acid

Methylcobalamin

Folate

Vitamin B9

Vitamin B12

Cobalamin

Cyanocobalamin

women who did not have intraepithelial neoplasia as a result of smear

women who have atypical squamous cells of undetermined significance (ASCUS) as a result of smear

Vitamin B12 and folate

Non-classified atypical squamous cells (ASCUS) is the most common abnormal cervical cytology (%39). The risk of cervical intraepithelial neoplasia 2-3 is 5% and the risk of carcinoma is around 0.1% after diagnosis. Mostly human papillomavirus (HPV) is responsible for this transition. Most of them are transient, but some infections become persistent and can progress into precancer and invasive cancer. In the process of progression to cancer; patients with cell cycle problems are thought to be at risk. In some studies, B12 and folate deficiency, which play a role in DNA synthesis and repair, have been shown to induce incorrect binding of uracil to DNA, leading to DNA breakage and repair disorder. Therefore, in this study, it has been aimed that the relation of presence of atypical squamous cells and HPV persistence with folate and vitamin B12 levels which effect on immune system.

Participants were divided into two groups according to their smear results; atypical squamous cells of undetermined significance (ASCUS) (study group: 100 patients) and women who did not have intraepithelial neoplasia as a result of smear (control group: 100 patients). Patients who had well preserved sufficient number of squamous epithelial cells, who did not have bleeding, fixation failure, inflammation or atrophy, and had negative cervical cytology smear were considered as control group. HPV test was also requested from the study group. B12 and folate blood levels were compared between the groups.

Can B12 and Folate Levels Predict HPV Penetration in Patients With ASCUS?

Serum Levels of Folate And Vitamine B12 in Patients Infected With HPV and Diagnosed Atypical Squamous Cells of Undetermined Significance in Cervical Cytology

the vitamine B12 levels in patients with ASCUS (+) smear.

the folate levels in patients with ASCUS (+) smear.

Sisli Hamidiye Etfal Training and Research Hospital

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Congenital Abnormalities

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

Vaccines

Those getting Gardasil vaccination for low grade Pap abnormality.

Historical group that did not get Gardasil.

Subjects are those getting gradasil vaccination already. This is really not an intervention

human papillomavirus vaccine L1, type 6,11,16,18

Dean A. Seehusen, MD, MPH

This project will compare the rate of regression of minimally abnormal Pap smears to normal in women who receive Gardasil to a historical control group.

Research hypothesis: Women with low grade cervical dysplasia on Papanicolaou (Pap) smear that receive Gardasil vaccination will revert to a normal within one year at a rate 33% higher than historical controls that did not receive Gardasil vaccination.

This study is looking for additional clinical outcomes in women who are already getting the Gardasil vaccination. We are not giving the vaccination as part of the research protocol. This point will be stressed to patients. Their participation or non-participation will not impact their ability to receive the vaccine series. Their participation only impacts whether or not we will contact them in the future and whether or not we will review their medical records.

Subjects will be enrolled into the study at the time of their presentation for colposcopy in the EAMC Family Medicine Clinic. Subjects will be screened for inclusion and exclusion criteria. Those found eligible will be consented for enrollment by one of the study investigators. Colposcopy records will also be searched for patients seen in the colposcopy clinic between the availability of Gardasil and the beginning of this study. Any patients who meet enrollment criteria will be contacted by phone and invited to participate in the study. These patients will be followed in the exact same way as patients enrolled upon presenting for the first time to the colposcopy clinic.

Patients will be given their first vaccination at the time of their colposcopy appointment unless they have already begun the vaccine series. Phone and email will be used to remind patients when they are due for their second and third vaccinations. Any study subject that does not receive the their 2nd or 3rd vaccine will be considered "partially vaccinated". They will not be removed from the protocol, however, because an intention-to-treat analysis is planned.

Study subjects will be followed prospectively for up to 15 months. 15 months was chosen because some patients may be late getting their one-year follow ups. AHLTA records and colposcopy clinic convenience files will be reviewed for each patient periodically. Patients who meet criteria to return to routine annual Pap smear, based on ASCCP guidelines, during the next 11 to 15 months will be considered as "reversion". Those patients who have ASCUS, + HPV, LGSIL, or HGSIL on Pap smear at 11 to 15 months past their original Pap smear will be considered "persistent". Historical control subjects will also be grouped into "reversion" and "persistent" using the same criteria.

Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities

Eisenhower Army Medical Center

Dean A. Seehusen/PI

Rare Diseases

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

At the colposcopy clinic, vaginal self-sample will be collected with the Flocked Swab (Noble Bioscience, Inc., Korea).

Flocked Swab

Physician collected cervical sample will be collected also at the colposcopy center with the Cervical Brush (Noble Bioscience, Inc., Korea).

Cervical Brush

The hrHPV assay used, will be the Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit and Realtime HPV HR-S Detection kit.

HPV assay

Jae Kwan Lee, MD, Ph.D.

Hyun Woong Cho, MD

Seung-hoe Song, MBE

Ji-young Lee

Jin Hwa Hong, MD, Ph.D.

Yung Taek Ouh, MD

Hyun-Woong Cho, MD

This study is a prospective observational study of human papillomavirus (HPV) testing using urine and self-collected vaginal samples for women who have atypical squamous cells of undetermined significance(ASCUS) or low grade squamous intraepithelial lesion(LSIL) on Pap test. Among women who are diagnosed with ASCUS and LSIL, HPV test is performed by collecting urine and self-collected vaginal sample in standardized condition before colposcopy, and evaluation will be performed as a primary screening test with cytology triage.

The samples are collected from patients referred to colposcopy because of prior cervical abnormalities on Pap test such as ASCUS and LSIL. The patient takes at home urine samples on the morning of visit to the colposcopy center. At the colposcopy center, self-collected vaginal samples are taken by the patient herself with a plastic brush (Flocked Swab, manufactured by Noble Bioscience, Inc.). Finally, the gynecologist takes a cervical sample with a plastic brush (Cervical Brush, manufactured by Noble Bioscience, Inc.).

Physician collected cervical samples, self-collected vaginal samples and urine samples are used to perform HPV testing with Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit and Realtime HPV HR-S Detection kit.

The Anyplex™ II HPV HR detection kit (manufactured by Seegene. Inc, Korea) is a new, multiplex, real-time polymerase chain reaction assay to detect individual 14 high-risk. (HR) human papillomavirus (HPV) types in a single tube.

The Roche Cobas® 4800 HPV test (manufactured by Cobas) is a novel molecular method based on real-time PCR (RT-PCR), with a fully automated system allowing quick and efficient sample processing. Cobas can detect the human papillomavirus type 16(HPV16), the human papillomavirus type 18(HPV18), 12 other high-risk HPVs (hrHPVs) (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and -68, as a pooled result), and the β-globin control independently in the same PCR.

Realtime HPV HR-S Detection kit (manufactured by Sejong Biomed Co, Korea) is a new, real-time polymerase chain reaction assay to detect HPV 16, HPV 18, 12 other high-risk HPVs (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and -68). Real-time HPV HR-S Detection Kit is based on accurate real-time PCR method as described, and it can detect 14 kinds of HPV type detection in a single test (HPV 16/18 genotype and others (UDG) -dUTP) system for the prevention of contamination, and a control agent (hemoglobin DNA, a human-derived DNA) as a whole process control was introduced into a high-risk genotype (12 genotypes other than HPV 16/18). It has high sensitivity and specificity for detection of high risk genotypes by increasing the reliability of the results.

The main goal of this study is to determine whether HPV testing using urine and self-collected sample is sensitive to detecting precancerous lesions such as cervical intraepithelial neoplasia(CIN)2/3 in patients diagnosed with ASCUS and LSIL on the Pap test. The colposcopy and histological findings will be used as the gold standard. In addition, the relative sensitivity and specificity for detecting HPV16, HPV18 and high risk HPV will be determined for each of the three HPV tests using urine and self-collected samples compared with the HPV tests using physician-collected samples.

Urine sample, vaginal self-sample and cervical cell sample collected by a gynecologist. No human DNA is extracted from the samples but the samples can contain HPV DNA.

HPV Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study

Human Papillomavirus(HPV) Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study

Absolute sensitivity and specificity for finding underlying cervical intraepithelial neoplasia(CIN)2+ of HPV testing(Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit and Realtime HPV HR-S Detection kit) on urine, self- and clinician-collected samples.

Relative sensitivity and specificity of hrHPV testing on vaginal self-samples and urine sample vs clinician-collected samples.

Concordance of the presence of HPV16, 18 and other high risk HPV genotyping results applied on urine, self- and clinician-collected samples

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Can B12 and Folate Levels Predict HPV Penetration in Patients With ASCUS?	NCT03903952	ASC-US Human Papilloma...	Vitamin B12 and...	30 Years - 65 Years	Sanliurfa Mehmet Akif Inan Education and Research Hospital
Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities	NCT00501189	Papillomavirus ...	human papilloma...	18 Years - 26 Years	Eisenhower Army Medical Center
HPV Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study	NCT03409471	ASC-US LSIL	Flocked Swab Cervical Brush HPV assay	20 Years - 60 Years	Korea University Guro Hospital
Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities	NCT00501189	Papillomavirus ...	human papilloma...	18 Years - 26 Years	Eisenhower Army Medical Center

Spots Global Cancer Trial Database for ascus

Every month we try and update this database with for ascus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ascus

Every month we try and update this database with for ascus cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ascus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.