NPC PatientsCANPCSSNCT03637634
The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study
An observational study of NPC Patients, run by Hai-Qiang Mai,MD,PhD.
Trial summary
The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study will investigate the long-term effects of nasopharyngeal carcinoma (NPC) and its associated therapies. A prospective and retrospective cohort study will be conducted through a multi-institutional collaboration. Read more about this study
- Who is it for?
- Ages Up to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- NPC Patients
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: NPC patients under 21 years old and their siblings
Who may be able to join
- Patients or their siblings must be informed of the investigational nature of this study and give written informed consent.
- Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II or III) before age 21 years at one of participating centers.
Who cannot join
- Already involved in other blind clinical trial.
- The information of tumour response evaluation and survival data cannot be obtained.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study will investigate the long-term effects of nasopharyngeal carcinoma (NPC) and its associated therapies. A prospective and retrospective cohort study will be conducted through a multi-institutional collaboration. This project will study children and adolescents exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, who are at increased risk of late-occurring adverse health outcomes. A group of sibling controls will be identified and data collected for comparison purposes.
Read the detailed description
The study will focus on the following objectives:
- Characterize survivors' health with respect to disease- and treatment-related factors.
- Investigate the consequences of various intensities of exposure to chemotherapy and/or radiation on health outcomes (e.g., cardiovascular, reproductive, second cancers, etc…).
- Compare the mortality experience of survivors with the general population.
- Characterize the health-related behaviors, patterns of medical care, and medical follow-up needs of survivors.
- Describe patterns of familial aggregation of cancer, including known (and variations of) cancer family syndromes.
- Collect and store biologic samples (saliva, blood, second tumor tissue) to correlate with health outcomes and use for future research.
- Conditions
- NPC Patients
- Keywords
- children and adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NPC survivors | Survivors of NPC, diagnosed under 21 years of age, between 1990 and 2030. This project will study children and young adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, for an increased risk of late-occurring events associated with excess mortality and morbidity. | |
| Sibling Controls | A group of sibling controls will be identified to provide: (1) the ability to make direct comparisons with the survivors, (2) data on outcomes in a non-cancer population, and (3) additional comparison group to determine the consistency of findings between data sources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival(OS)
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Measured: 5 years
Secondary outcomes (4)
Progress-free survival(PFS)
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up
Measured: 5 years
Locoregional failure-free survival(LRFS)
The LRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit
Measured: 5 years
Distant metastasis-free survival(DMFS)
The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit
Measured: 5 years
Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
The shortterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NPC PatientsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hai-Qiang Mai,MD,PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangdong Provincial People's Hospital, First Affiliated Hospital of Jinan University, Nanfang Hospital, Southern Medical University, Affiliated Cancer Hospital of Shantou University Medical College, Zhanjiang Cancer Hospital, Zhongnan Hospital, First People's Hospital of Foshan, Dongguan People's Hospital, Fifth Affiliated Hospital, Sun Yat-Sen University, Shenzhen Second People's Hospital, Jiangmen Central Hospital, Yuebei People's Hospital, Hunan Cancer Hospital, Cancer Hospital of Guizhou Province, Fudan University, Fujian Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital of Zhengzhou University, Zhejiang Cancer Hospital, Sichuan Cancer Hospital and Research Institute, Shandong Cancer Hospital and Institute, Jiangsu Cancer Institute & Hospital, Jiangxi Provincial Cancer Hospital, Second Affiliated Hospital of Nanchang University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking University Cancer Hospital & Institute, Cancer Hospital of Guangxi Medical University, Tongji Hospital
- Responsible party
- Sponsor-investigator, Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
- Investigators
- Hai Mai, Dr, Study chair, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637634
- Sponsor's protocol ID
- Childhood NPC
- Acronym
- CANPCSS
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wei WI, Sham JS. Nasopharyngeal carcinoma. Lancet. 2005 Jun 11-17;365(9476):2041-54. doi: 10.1016/S0140-6736(05)66698-6.
PubMed 15950718Levine PH, Connelly RR, Easton JM. Demographic patterns for nasopharyngeal carcinoma in the United States. Int J Cancer. 1980 Dec 15;26(6):741-8. doi: 10.1002/ijc.2910260607.
PubMed 7216543Ingersoll L, Woo SY, Donaldson S, Giesler J, Maor MH, Goffinet D, Cangir A, Goepfert H, Oswald MJ, Peters LJ. Nasopharyngeal carcinoma in the young: a combined M.D. Anderson and Stanford experience. Int J Radiat Oncol Biol Phys. 1990 Oct;19(4):881-7. doi: 10.1016/0360-3016(90)90008-8.
PubMed 2120164Downing NL, Wolden S, Wong P, Petrik DW, Hara W, Le QT. Comparison of treatment results between adult and juvenile nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1064-70. doi: 10.1016/j.ijrobp.2008.12.030. Epub 2009 Mar 26.
PubMed 19327901
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study
- ClinicalTrials.gov ID
- NCT03637634
- Acronym / sponsor ID
- CANPCSS / Childhood NPC
- Conditions
- NPC Patients
- Keywords
- children and adolescents
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hai-Qiang Mai,MD,PhDUniversity, hospital or other
- Collaborators
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangdong Provincial People's Hospital, First Affiliated Hospital of Jinan University, Nanfang Hospital, Southern Medical University, Affiliated Cancer Hospital of Shantou University Medical College, Zhanjiang Cancer Hospital, Zhongnan Hospital, First People's Hospital of Foshan, Dongguan People's Hospital, Fifth Affiliated Hospital, Sun Yat-Sen University, Shenzhen Second People's Hospital, Jiangmen Central Hospital, Yuebei People's Hospital, Hunan Cancer Hospital, Cancer Hospital of Guizhou Province, Fudan University, Fujian Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital of Zhengzhou University, Zhejiang Cancer Hospital, Sichuan Cancer Hospital and Research Institute, Shandong Cancer Hospital and Institute, Jiangsu Cancer Institute & Hospital, Jiangxi Provincial Cancer Hospital, Second Affiliated Hospital of Nanchang University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking University Cancer Hospital & Institute, Cancer Hospital of Guangxi Medical University, Tongji Hospital
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study will investigate the long-term effects of nasopharyngeal carcinoma (NPC) and its associated therapies. A prospective and retrospective cohort study will be conducted through a multi-institutional collaboration. This project will study children and adolescents exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, who are at increased risk of late-occurring adverse health outcomes. A group of sibling controls will be identified and data collected for comparison purposes.
Detailed description
The study will focus on the following objectives:
- Characterize survivors' health with respect to disease- and treatment-related factors.
- Investigate the consequences of various intensities of exposure to chemotherapy and/or radiation on health outcomes (e.g., cardiovascular, reproductive, second cancers, etc…).
- Compare the mortality experience of survivors with the general population.
- Characterize the health-related behaviors, patterns of medical care, and medical follow-up needs of survivors.
- Describe patterns of familial aggregation of cancer, including known (and variations of) cancer family syndromes.
- Collect and store biologic samples (saliva, blood, second tumor tissue) to correlate with health outcomes and use for future research.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPC survivors | – | –Survivors of NPC, diagnosed under 21 years of age, between 1990 and 2030. This project will study children and young adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, for an increased risk of late-occurring events associated with excess mortality and morbidity. |
| Sibling Controls | – | –A group of sibling controls will be identified to provide: (1) the ability to make direct comparisons with the survivors, (2) data on outcomes in a non-cancer population, and (3) additional comparison group to determine the consistency of findings between data sources. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- NPC patients under 21 years old and their siblings
Key inclusion criteria (2 listed)
- Patients or their siblings must be informed of the investigational nature of this study and give written informed consent.
Key exclusion criteria (2 listed)
- Already involved in other blind clinical trial.
- The information of tumour response evaluation and survival data cannot be obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival(OS)
Time frame: 5 years
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
4 secondary outcomes
Progress-free survival(PFS)
Time frame: 5 years
Locoregional failure-free survival(LRFS)
Time frame: 5 years
Distant metastasis-free survival(DMFS)
Time frame: 5 years
Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Background: PubMed 15950718Wei WI, Sham JS. Nasopharyngeal carcinoma. Lancet. 2005 Jun 11-17;365(9476):2041-54. doi: 10.1016/S0140-6736(05)66698-6.
- Background: PubMed 7216543Levine PH, Connelly RR, Easton JM. Demographic patterns for nasopharyngeal carcinoma in the United States. Int J Cancer. 1980 Dec 15;26(6):741-8. doi: 10.1002/ijc.2910260607.
- Background: PubMed 2120164Ingersoll L, Woo SY, Donaldson S, Giesler J, Maor MH, Goffinet D, Cangir A, Goepfert H, Oswald MJ, Peters LJ. Nasopharyngeal carcinoma in the young: a combined M.D. Anderson and Stanford experience. Int J Radiat Oncol Biol Phys. 1990 Oct;19(4):881-7. doi: 10.1016/0360-3016(90)90008-8.
- Background: PubMed 19327901Downing NL, Wolden S, Wong P, Petrik DW, Hara W, Le QT. Comparison of treatment results between adult and juvenile nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1064-70. doi: 10.1016/j.ijrobp.2008.12.030. Epub 2009 Mar 26.
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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.
Hai Mai, Dr study chair
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of NPC Patients, run by Hai-Qiang Mai,MD,PhD.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiqiang Mai, Dr (86-20-8734-3643, maihq@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival(OS) (time frame: 5 years). 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 NCT03637634, 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 28 Aug 2018.