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STUDY OF THE STAINING SOLUTION MEDIATED BY THE FOLATO RECEIVER (FRD BY ITS ACRONYMS IN ENGLISH) IN THE DETECTION OF CERVICAL CANCER.

STUDY OF THE STAINING SOLUTION MEDIATED BY THE FOLATO RECEIVER (FRD BY ITS ACRONYMS IN ENGLISH) IN THE DETECTION OF CERVICAL CANCER.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-047-18
Enrollment
800
Registered
2019-04-03
Start date
2019-01-01
Completion date
Unknown
Last updated
2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

(FRD) EPITELIAL CELL STAINING SOLUTION Type of group
NAME OF THE INTERVENTION: PLACE SOLUTION OF STAINING IN UTERINE NECK. PHARMACEUTICAL FORM AND VIA ADMINISTRATION: SOLUTION, FOLIC ACID 1% + BLUE OF METHYLENE 0.1% + ASCORBIC ACID 0.8% + HYDROXYBUTYL ACID 0.05% + ACETIC ACID 5% + SYLFOXIDE. DOSAGE: 1 ONLY DOSAGE DURATION OF TREATMENT_1 ONLY DOSE.

Sponsors

GY HIGHLAND BIOTECH LLC,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -MUJER BETWEEN 20-60 -DIAGNOSIS: WOMAN WHO NEEDS TO BE PERFORMED GYNECOLOGICAL PELVIC EXAMINATION FOR CERVICAL CANCER DISCARD. WOMEN WHO HAVE REGULAR CONDITIONS TO PERFORM A COLPOSCOPY. (DO NOT HAVE VAGINAL SHOWS, NO SEXUAL RELATIONS AND NOT BEING MENTRUANDO)

Exclusion criteria

Exclusion criteria: MUJERES WITH TOTAL HYSTERECTOMY. WOMEN WHO HAD CERVICAL SURGERY, INCLUDING CONIZATION, PROCEDURE OF ELECTRO SURGICAL EXCISION (LEEP, OF ITS ABBREVIATIONS IN ENGLISH) AND INFRARED RAYS. WOMEN WITH SERIOUS CERVICAL HEMORRHAGE OF CONTACT-PREGNANT WOMEN - WOMEN WITH ACUTE INFLAMMATION OF THE UTERINE NECK AND / OR THE VAGINA - WOMEN WHO WERE ALREADY DIAGNOSED WITH CONNIC2 + WOMEN WHO USE INJECTABLE OR ORAL DRUGS AGAINST CANCER

Design outcomes

Primary

MeasureTime frame
Outcome name:EXAMINATION WITH THE SPECULO GINECOLOGIA Measure:REDUCTION EVALUATION: EVALUATE THE CLINICAL PERFORMANCE OF THE MEDIATED STAINING SOLUTION BY THE FOLATO RECEIVER (FRD) IN THE DETECTION OF CERVICAL NEOPLASTIC LESIONS (NIC2 +) DURING THE EXAMINATION WITH GYNECOLOGIST SPECULO Timepoints:ANNUAL CONTROL WITH CITOLOGY

Secondary

MeasureTime frame
Outcome name:INDICE DE EVALUACION DE PRUEBA DE DETECCION Measure:DETECTION TEST Timepoints:HISTOPATHOLOGICAL RESULT TIME 72 HOURS

Countries

Georgia, Peru

Contacts

Public ContactRAUL YEPEZ

PERUVIAN CLINICAL RESEARCH S.A.C

r.yepez@pcr.pe999962145

Outcome results

None listed

Source: REPEC (via WHO ICTRP)