Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions

• Sponsor: University of Luebeck (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02238990
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 195
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The following trial is a multicenter and prospective research trial of the colposcopy unit of luebeck university and the national research center in Borstel, Germany.

The study is to identify and evaluate new biomarkers in human papilloma virus (HPV) associated malignancies and its preinvasive lesions of the cervix uteri. Fresh tissue samples being removed during conizations and/or hysterectomies are to be fixed in HOPE's solution and analyzed according to their transcriptomes and methylosome. The hereby found candidates are to be validated using immunohistochemistry and RT [real-time] -PCR [polymerase chain reaction].

The project is meant to be followed by continuous studies developing a new test describing the malignant potential of HPV associated genital lesions.

Condition or Disease	Intervention/Treatment	Phase
Evaluation of New Tissue Biomarkers for Cervical Cancer

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Biomarkerscreening Via Transcriptome and Methylosome Analysis in Cervical Cancer and Its Preinvasive Lesions
• Actual Study Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2030
• Anticipated Study Completion Date: Dec 1, 2030

Outcome Measures

Primary Outcome Measures

1. CIN III (cervical intraepithelial neoplasia) lesions [three years]

   number of CIN III lesions

2. cervical cancer [three years]

   number of cervical cancer probes

3. HPV [three years]

   number and type of HPV infection of the analyzed probes

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Positive informed consent

• Patients with suspected preinvasive genital lesion

• Patients with confirmed genital lesion (both preinvasive and invasive)

• Contact via dept. of obs/gyn of luebeck university

• Complete set of data

Exclusion Criteria:

• Incomplete set of data

• Negative informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Luebeck University, Department for obstetrics and gynecology	Luebeck	Schleswig Holstein	Germany	D-23538

Sponsors and Collaborators

• University of Luebeck

Investigators

• Principal Investigator: Daniel Beyer, PD Dr., University of Luebeck
• Principal Investigator: Torsten Goldmann, Prof. Dr., Forschungszentrum Borstel

Study Documents (Full-Text)

None provided.

More Information

Publications

• Apgar BS, Kittendorf AL, Bettcher CM, Wong J, Kaufman AJ. Update on ASCCP consensus guidelines for abnormal cervical screening tests and cervical histology. Am Fam Physician. 2009 Jul 15;80(2):147-55.
• Gagné HM. Colposcopy of the vagina and vulva. Obstet Gynecol Clin North Am. 2008 Dec;35(4):659-69; x. doi: 10.1016/j.ogc.2008.10.002. Review.
• Massad LS, Jeronimo J, Katki HA, Schiffman M; National Institutes of Health/American Society for Colposcopy and Cervical Pathology Research Group. The accuracy of colposcopic grading for detection of high-grade cervical intraepithelial neoplasia. J Low Genit Tract Dis. 2009 Jul;13(3):137-44. doi: 10.1097/LGT.0b013e31819308d4.

• Responsible Party: Daniel Alexander Beyer, Priv.-Doz.Dr.med.habil., University of Luebeck
• ClinicalTrials.gov Identifier: NCT02238990
• Other Study ID Numbers: UKSH-HL-14-099; UKSH-HL-14-099
• First Posted: Sep 12, 2014
• Last Update Posted: May 31, 2022
• Last Verified: May 1, 2022

• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

No Results Posted as of May 31, 2022