Cancer SurvivorPhase 2NCT01492582

Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

A Phase 2 study testing quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58), laboratory biomarker analysis and survey administration in people with Cancer Survivor and Prevention of Human Papillomavirus Infection, run by University of Alabama at Birmingham at 5 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine initiation among young cancer survivors, and (2) determining the immune response to and safety/tolerability of the quadrivalent and… Read more about this study

Who is it for?: Ages 9 to 26 years
Conditions the study is for: Cancer Survivor, Prevention of Human Papillomavirus Infection
What is being tested?: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58), laboratory biomarker analysis and survey administration
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,499 participants
Where: 5 sitesUnited States
Study dates: Jul 2012to 20 Jul 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 9 to 26 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

AIM 1 (SURVEY) (AIM 1 is closed to enrollment)
Cancer survivor
Between 12 and 60 months after completion of cancer therapy (chemotherapy, radiation, hematopoietic cell transplant [HCT])
Scheduled for a return clinic visit at one of the participating institutions
English or Spanish-speaking
Willing to provide informed consent/assent for study participation

Show all 13Show fewer

AIM 2 (VACCINE EVALUATION)
Meets all inclusion criteria outlined in Aim 1
Survey response indicated no prior history of HPV vaccination OR patient has no prior history of HPV vaccination by self - or parent/caregiver-report
English or Spanish-speaking
Medical clearance from treating clinician for study participation
Agrees to return to participating institution for 3 HPV vaccine injections
Willing to provide informed consent/assent for study participation

Who cannot join

AIM 2 (VACCINE EVALUATION)
Allergy to any component of the HPV vaccine including yeast and aluminum
Thrombocytopenia (platelet count < 50K) or coagulation disorder that would contraindicate intramuscular injection
Transfusion of blood products or intravenous immune globulin within 3 months of study entry
Female, and a) currently pregnant or lactating, or b) of childbearing potential and unwilling to avoid pregnancy during the vaccine phase of study (beginning at Day 1 and continuing until at least 4 weeks after all 3 vaccine doses have been administered)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of Michigan
Ann Arbor, Michigan, 48109
Emory University School Of Medicine
Atlanta, Georgia, 30308
University of Alabama at Birmingham
Birmingham, Alabama, 35233
City of Hope Medical Center
Duarte, California, 91010
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105

Other trials in United States

About this study

Official title: Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial

Read the detailed description

PRIMARY OBJECTIVES:

Using a cross-sectional survey approach, estimate the prevalence of HPV vaccine non-initiation: a) Examine sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.

II. Using a single-arm, phase II, open-label, prospective longitudinal trial design, to evaluate the 3-dose HPV quadrivalent (HPV4) and nonavalent (HPV9) vaccine series and measure the following endpoints: a) Determine immunogenicity following the third and final vaccine dose; b) Identify clinical/host factors influencing immunogenicity; c) Determine the safety/tolerability of the HPV vaccine in cancer survivors.

III. Evaluate the persistence of antibody response at 2 years post vaccine initiation and identify clinical/host factors influencing response persistence.

OUTLINE:

AIM 1 (SURVEY): Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination.

AIM 2 (VACCINE EVALUATION): Patients not previously immunized against HPV receive quadrivalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, for patients enrolled on or before 3/1/16) or the nonavalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, -31, -33, -45, -52, -58, for patients enrolled after 3/1/16) intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.

Conditions: Cancer Survivor, Prevention of Human Papillomavirus Infection
Being tested: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58), laboratory biomarker analysis, survey administration, medical chart review

What participants receive

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

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58)Biological
Also called Gardasil, Gardasil 9
Given IM
laboratory biomarker analysisOther
Correlative studies
survey administrationOther
Ancillary studies
medical chart reviewOther
Also called chart review
Ancillary studies

Study groups in NCT01492582
Study group	Role	What they receive
Prevention (vaccine therapy)	Experimental	Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. Receives: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58); Other: laboratory biomarker analysis; Other: survey administration; Other: medical chart review

What is being measured

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

Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey])
The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years
Measured: At baseline
Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation])
To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population.
Measured: 1 month following vaccination dose #3
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population.
Measured: Dose 1 through Month 7

Timeline

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

Jul 201220 Jul 2020

First posted15 Dec 2011 (estimated)
Study startJul 2012
Primary completion8 Feb 2019
Study completion20 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Cancer SurvivorStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,499 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01492582
Sponsor's protocol ID: UAB-F141204009/UAB-X141204010
Other IDs: NCI-2011-03654, 1R01CA166559, Merck-IISP#40083, COH-11034
Status last verified: Oct 2021
First submitted: 12 Dec 2011
Last updated: 27 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Landier W, Bhatia S, Wong FL, York JM, Flynn JS, Henneberg HM, Singh P, Adams K, Wasilewski-Masker K, Cherven B, Jasty-Rao R, Leonard M, Connelly JA, Armenian SH, Robison LL, Giuliano AR, Hudson MM, Klosky JL. Immunogenicity and safety of the human papillomavirus vaccine in young survivors of cancer in the USA: a single-arm, open-label, phase 2, non-inferiority trial. Lancet Child Adolesc Health. 2022 Jan;6(1):38-48. doi: 10.1016/S2352-4642(21)00278-9. Epub 2021 Nov 10.
PubMed 34767765
York JM, Klosky JL, Chen Y, Connelly JA, Wasilewski-Masker K, Giuliano AR, Robison LL, Wong FL, Hudson MM, Bhatia S, Landier W. Patient-Level Factors Associated With Lack of Health Care Provider Recommendation for the Human Papillomavirus Vaccine Among Young Cancer Survivors. J Clin Oncol. 2020 Sep 1;38(25):2892-2901. doi: 10.1200/JCO.19.02026. Epub 2020 Jun 18.
PubMed 32552278
Cherven B, Castellino SM, Chen Y, Wong FL, York JM, Wasilewski-Masker K, Hudson MM, Bhatia S, Klosky JL, Landier W. Intent and subsequent initiation of human papillomavirus vaccine among young cancer survivors. Cancer. 2019 Nov 1;125(21):3810-3817. doi: 10.1002/cncr.32379. Epub 2019 Jul 10.
PubMed 31291010
Klosky JL, Hudson MM, Chen Y, Connelly JA, Wasilewski-Masker K, Sun CL, Francisco L, Gustafson L, Russell KM, Sabbatini G, Flynn JS, York JM, Giuliano AR, Robison LL, Wong FL, Bhatia S, Landier W. Human Papillomavirus Vaccination Rates in Young Cancer Survivors. J Clin Oncol. 2017 Nov 1;35(31):3582-3590. doi: 10.1200/JCO.2017.74.1843. Epub 2017 Aug 24.
PubMed 28837404

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
RecruitingPhase 3
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
Recruiting
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
Pediatric Brain Tumor

All Cancer Survivor trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial
ClinicalTrials.gov ID: NCT01492582
Acronym / sponsor ID: UAB-F141204009/UAB-X141204010
Conditions: Cancer Survivor, Prevention of Human Papillomavirus Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,499 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), Merck Sharp & Dohme LLC
Study start: Jul 2012
Primary completion: 8 Feb 2019 (actual)
Study completion: 20 Jul 2020 (actual)
First posted: 15 Dec 2011 (estimated)
Results: Posted 30 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

Using a cross-sectional survey approach, estimate the prevalence of HPV vaccine non-initiation: a) Examine sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.

III. Evaluate the persistence of antibody response at 2 years post vaccine initiation and identify clinical/host factors influencing response persistence.

OUTLINE:

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Prevention (vaccine therapy)	Experimental	Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58), Other: laboratory biomarker analysis, Other: survey administration, Other: medical chart reviewPatients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.

Who may qualify

Ages: 9 to 26 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (13 listed)

AIM 1 (SURVEY) (AIM 1 is closed to enrollment)
Cancer survivor
Between 12 and 60 months after completion of cancer therapy (chemotherapy, radiation, hematopoietic cell transplant [HCT])
Scheduled for a return clinic visit at one of the participating institutions
English or Spanish-speaking

Key exclusion criteria (5 listed)

AIM 2 (VACCINE EVALUATION)
Allergy to any component of the HPV vaccine including yeast and aluminum
Thrombocytopenia (platelet count < 50K) or coagulation disorder that would contraindicate intramuscular injection
Transfusion of blood products or intravenous immune globulin within 3 months of study entry
Female, and a) currently pregnant or lactating, or b) of childbearing potential and unwilling to avoid pregnancy during the vaccine phase of study (beginning at Day 1 and continuing until at least 4 weeks after all 3 vaccine doses have been administered)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58)Also: Gardasil, Gardasil 9Given IM	Biological	Prevention (vaccine therapy)
laboratory biomarker analysisCorrelative studies	Other	Prevention (vaccine therapy)
survey administrationAncillary studies	Other	Prevention (vaccine therapy)
medical chart reviewAlso: chart reviewAncillary studies	Other	Prevention (vaccine therapy)

Primary outcome

Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey])
Time frame: At baseline
The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years
Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation])
Time frame: 1 month following vaccination dose #3
To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population.
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
Time frame: Dose 1 through Month 7
To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population.

Results and safety

Results posted to the registry on 30 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prevention (Vaccine Therapy)	453	384
Survey Arm	1,046	982

Primary outcome: Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey])

Time frame: At baseline. Count of participants. Unit: Participants

Measure	Survey Participants n = 982
Value	179

Population analysed: Participants who returned an evaluable survey

Primary outcome: Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation])

Time frame: 1 month following vaccination dose #3. Geometric mean (Standard Deviation). Unit: mMu/mL

Measure	Quadrivalent Anti-HPV 16, Male, Age 9-15 Years n = 65	Quadrivalent Anti-HPV 16, Female, Age 9-15 Years n = 51	Quadrivalent Anti-HPV 16, Male, Age 16-26 Years n = 65	Quadrivalent Anti-HPV 16, Female, Age 16-26 Years n = 28	Nonavalent Anti-HPV 16, Male, Age 9-15 Years n = 53	Nonavalent Anti-HPV 16, Female, Age 9-15 Years n = 41	Nonavalent Anti-HPV 16, Male, Age 16-26 Years n = 32	Nonavalent Anti-HPV 16, Female, Age 16-26 Years n = 23	Quadrivalent Anti-HPV 18, Male, Age 9-15 Years n = 66	Quadrivalent Anti-HPV 18, Female, Age 9-15 Years n = 54	Quadrivalent Anti-HPV 18, Male, Age 16-26 Years n = 68	Quadrivalent Anti-HPV 18, Female, Age 16-26 Years n = 30	Nonavalent Anti-HPV 18, Male, Age 9-15 Years n = 50	Nonavalent Anti-HPV 18, Female, Age 9-15 Years n = 41	Nonavalent Anti-HPV 18, Male, Age 16-26 Years n = 32	Nonavalent Anti-HPV 18, Female, Age 16-26 Years n = 28
Value	16134.57 (14722.06)	15209.73 (15638.30)	8740.02 (9625.61)	6107.32 (6609.07)	16419.64 (14756.37)	11763.60 (8082.14)	10770.38 (11166.73)	11522.87 (10443.38)	3472.21 (3769.68)	2638.33 (2695.70)	1920.01 (2553.81)	1009.90 (990.48)	5599.80 (4522.19)	3457.20 (2510.32)	3013.39 (3194.84)	3483.29 (6869.27)

Quadrivalent Anti-HPV 16, Male, Age 9-15 Years: lower bound one-sided CI of GMT ratio: 1.74
Quadrivalent Anti-HPV 16, Female, Age 9-15 Years: lower bound one-sided CI of GMT ratio: 1.76
Quadrivalent Anti-HPV 16, Male, Age 16-26 Years: lower bound one-sided CI of GMT ratio: 2.15

Primary outcome: Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])

Time frame: Dose 1 through Month 7. Number. Unit: participants

Measure	Prevention (Vaccine Therapy)- Quadrivalent n = 253	Nonavalent Vaccine n = 182
Injection site - Pain, any	90	84
Injection site - Swelling, any	15	15
Injection site - Erythema, any	15	17
Systemic - Headache	51	33
Systemic - Fever	17	15
Systemic - Nausea	29	41
Systemic - Dizziness	5	2
Systemic - Fatigue	47	24

Prevention (Vaccine Therapy)- Quadrivalent: p <0.001, Chi-squared, Corrected
Prevention (Vaccine Therapy)- Quadrivalent: p = 0.03, Chi-squared, Corrected
Prevention (Vaccine Therapy)- Quadrivalent: p = 0.48, Chi-squared, Corrected

Population analysed: Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.

Adverse events

Time frame: Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prevention (Vaccine Therapy)- Quadrivalent	11 of 253 (4.3%)	129 of 253 (51%)	0 of 253
Prevention (Vaccine Therapy)- Nonavalent Vaccine	7 of 182 (3.8%)	108 of 182 (59.3%)	0 of 182

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34767765Landier W, Bhatia S, Wong FL, York JM, Flynn JS, Henneberg HM, Singh P, Adams K, Wasilewski-Masker K, Cherven B, Jasty-Rao R, Leonard M, Connelly JA, Armenian SH, Robison LL, Giuliano AR, Hudson MM, Klosky JL. Immunogenicity and safety of the human papillomavirus vaccine in young survivors of cancer in the USA: a single-arm, open-label, phase 2, non-inferiority trial. Lancet Child Adolesc Health. 2022 Jan;6(1):38-48. doi: 10.1016/S2352-4642(21)00278-9. Epub 2021 Nov 10.
Derived from this study: PubMed 32552278York JM, Klosky JL, Chen Y, Connelly JA, Wasilewski-Masker K, Giuliano AR, Robison LL, Wong FL, Hudson MM, Bhatia S, Landier W. Patient-Level Factors Associated With Lack of Health Care Provider Recommendation for the Human Papillomavirus Vaccine Among Young Cancer Survivors. J Clin Oncol. 2020 Sep 1;38(25):2892-2901. doi: 10.1200/JCO.19.02026. Epub 2020 Jun 18.
Derived from this study: PubMed 31291010Cherven B, Castellino SM, Chen Y, Wong FL, York JM, Wasilewski-Masker K, Hudson MM, Bhatia S, Klosky JL, Landier W. Intent and subsequent initiation of human papillomavirus vaccine among young cancer survivors. Cancer. 2019 Nov 1;125(21):3810-3817. doi: 10.1002/cncr.32379. Epub 2019 Jul 10.
Derived from this study: PubMed 28837404Klosky JL, Hudson MM, Chen Y, Connelly JA, Wasilewski-Masker K, Sun CL, Francisco L, Gustafson L, Russell KM, Sabbatini G, Flynn JS, York JM, Giuliano AR, Robison LL, Wong FL, Bhatia S, Landier W. Human Papillomavirus Vaccination Rates in Young Cancer Survivors. J Clin Oncol. 2017 Nov 1;35(31):3582-3590. doi: 10.1200/JCO.2017.74.1843. Epub 2017 Aug 24.

Related trials for Cancer Survivor

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
RecruitingPhase 3
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
Recruiting
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
Pediatric Brain Tumor

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wendy Landier, PhD, CRNP principal investigator

University of Alabama at Birmingham

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 5 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 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey]) (time frame: At baseline). The study lists 3 primary outcomes in all. 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 NCT01492582, which also lists 4 linked publications.

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 27 Oct 2021.