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Cervical Intraepithelial NeoplasiaPhase 1PERCAPSNCT01338051

The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru

A Phase 1 study testing Gardasil in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Preventive Oncology International, Inc. at 2 sites in Peru.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project will use a community based participatory research orientation to develop a model for large scale "campaign" preventive healthcare interventions. The investigators have considerable expertise with cervical cancer screening and HPV vaccination. Read more about this study

Who is it for?
Ages 30 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Gardasil
Type of treatment
Injection or infusion
How many people
642 participants
Where
2 sitesPeru
Study dates
May 2011to Apr 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Non pregnant women 30-45 years of age in Manchay, and in Iquitos, with female children or grandchildren ages 10-13 who they are willing to enroll in the study to receive Gardasil vaccination.
  • No screening or knowledge of the results of a Pap Test in the last 5 years
  • No hysterectomy
  • No prior pelvic radiation.
  • Willing to sign consent form
  • Female children and grandchildren of a participating women ages 10-13 years
Show all 11Show fewer
  • No acute illnesses (clinically evident according to vaccinating staff) - such as fever, nausea, vomiting, diarrhea
  • No previous vaccination with Gardasil
  • No reactions to previous dose in their vaccination series
  • No known yeast allergy
  • Willing to participate

Who cannot join

  • Patients will be excluded in the study based on the following criteria:
  • Males
  • Women younger than 30 years old and older than 45 years old.
  • Women without female children or grandchildren age 10-13 or who are unwilling to enroll their 10-13 year old female children or grandchildren to receive Gardasil.
  • Pregnant women.
  • Patients with known history of hysterectomy or radiation for a pelvic cancer.
Show all 14Show fewer
  • Refusal to participate
  • Males
  • Girls younger than 10 years old, and older than 13 years.
  • acute illnesses (clinically evident according to vaccinating staff) - such as fever, nausea, vomiting, diarrhea
  • previous vaccination with Gardasil
  • reactions to a previous dose in their vaccination series
  • known yeast allergy
  • Refusal to participate

Trial locations and contacts

2 sites in 1 country.

Peru2 sites

  • Centro de Salud Bellavista Nanay

    Iquitos, Loreto, 065

  • Centro de Salud Portada de Manchay

    Manchay, Lima region

Other trials in Peru

About this study

Official title: The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru (PERCAPS)

This project will use a community based participatory research orientation to develop a model for large scale "campaign" preventive healthcare interventions. The investigators have considerable expertise with cervical cancer screening and HPV vaccination. The investigators also have well tested methodologies for cervical cancer screening that are highly effective, including self-sampling for HPV and improved specimen transport systems. Therefore, the investigators will use these medical interventions as the model preventive health interventions for this project.

Read the detailed description

Our research group has recently demonstrated that a self-collected cervico-vaginal sample tested with a very high throughput HR-HPV assay is as sensitive has a direct endocervical physician collected sample. Teamed with a non-liquid transport media the investigators believe the technology is solved to reach large populations in a short period of time. With the majority of the world's medically underserved now living in middle income countries it is not necessary to think simple and small to reach the Earth's needy. The investigators can think high tech and high throughput. The massive volumes possible, with proper organization, will control the per/patient cost. The investigators will think "events", not continuous care. Clearly continuous care is the only way to adequately provide the needed care for many problems. However, many interventions can be confined to events which organize large screening or vaccination days and only when positives are identified from the detection algorithm does the healthcare staff become involved for management. The investigators spend an enormous amount of resources identifying the majority of people who will ultimately test negative. The more local the paradigms and the more involved the community in designing the program, the greater will be the participation and the lost to follow-up segment will shrink. This mother, child, screen, treat and vaccinate program will use cervical cancer prevention as the target preventive healthcare intervention. Using community based research orientation the project will begin with a 3 day education program and collaborative meeting with the women leaders of the communities (promotoras). Collectively the investigators will develop the model for the community to advertise, educate, recruit, register, self-collect the specimens, deliver the samples, and report the results. In addition the logistics of the 3 vaccination schedule for the female children will be organized. The medical staff will be involved only with the management of the positives and the vaccine administration. The observational measures will focus on assessing how effectively each of the steps was accomplished.

Being tested
Gardasil
Keywords
Community based participatory research
Medical subject headings
Uterine Cervical Dysplasia, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GardasilBiological

    Gardasil will be administered to 10-13 year old daughters and granddaughters of study participants according to manufacturers recommended schedule of administration. Gardasil is supplied as 0.5-mL suspension for intramuscular injection at the following schedule: 0, 2 months, 6 months.

    DOSAGE FORMS AND STRENGTHS • 0.5-mL suspension for injection as a single-dose vial and prefilled syringe.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of key study processes used in the process of implementing a mother/child screen, treat and vaccinate program in Iquitos, Peru.

    The investigators will evaluate community participation, lost to follow up and potential sustainability. One on one interviews with participants will be conducted by trained medical staff. Additional measures to success will be gathered from interviews with promotoras, participating health services staff and recoeded observation. These analyses are descriptive in nature.

    Measured: Interview with participants will occur at approximately one month after 2nd vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
642 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01338051
Sponsor's protocol ID
PERCAPS I
Acronym
PERCAPS
Status last verified
Apr 2014
First submitted
16 Apr 2011
Last updated
21 Apr 2014
Results posted
No
Data monitoring committee
No

Publications

  • Levinson KL, Abuelo C, Salmeron J, Chyung E, Zou J, Belinson SE, Wang G, Ortiz CS, Vallejos CS, Belinson JL. The Peru Cervical Cancer Prevention Study (PERCAPS): the technology to make screening accessible. Gynecol Oncol. 2013 May;129(2):318-23. doi: 10.1016/j.ygyno.2013.01.026. Epub 2013 Feb 4.

    PubMed 23385153

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gardasil in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Preventive Oncology International, Inc. at 2 sites in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of key study processes used in the process of implementing a mother/child screen, treat and vaccinate program in Iquitos, Peru. (time frame: Interview with participants will occur at approximately one month after 2nd vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01338051, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.

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