Non-Hodgkin's LymphomaNCT01704742
Prospective Study of Lymphoproliferative Diseases
An observational study of Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma, run by West Virginia University at 2 sites in 2 countries.
Trial summary
This study will help researchers learn more about non-Hodgkin's lymphoma and Hodgkin's lymphoma and how it is treated in Kenya. Researchers want to see if having certain viruses like Epstein Barr Virus (EBV), Human Immunodeficiency Virus (HIV), and Kaposi's Sarcoma Herpes Virus (KSHV) affects lymphoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at Kenyatta National Hospital in Kenya being treated for non-Hodgkin's lymphoma or Hodgkin's lymphoma.
Who may be able to join
- All subjects regardless of age, sex or HIV serostatus must have biopsy-proven non-Hodgkin's (NHL), including primary effusion lymphoma, Hodgkin's lymphoma (HD) or other lymphoproliferative disorder (e.g., Castleman's disease) with measurable or evaluable stage I through IV disease.
- [Note: Lymphomas will be categorized on the basis of current WHO classification scheme, but it is recognized that initial pathological categorization at time of study enrollment will more than likely be classified or graded as low-, intermediate-, or high-grade lymphoma by Working Formulation criteria. This is the current standard of practice in Kenya.]
- All subjects must receive some form of systemic chemotherapy. Subjects not receiving chemotherapy of any kind are not eligible. Subjects must not have had any prior chemotherapy for lymphoma.
- Subjects may have received prior radiotherapy for localized stage I or stage II disease that is clearly documented to have progressed beyond initial radiotherapy ports.
- All subjects must give written informed consent to participate on study. In Kenya, a child is considered < 18 years of age and an adult ≥ 18 years of age. All children will have their parental or legal guardian provide consent.. Children between the ages of 7 and < 18 years old should be given the opportunity to provide their assent. For children between the ages of 7 and 11 years old this should be done using the parental consent form assent statement. For children > 11 years old assent should be documented using the IRB approved assent form.
Who cannot join
- Subjects who do not fulfill the criteria as listed in Sections 3.1.1 through 3.1.4 are ineligible.
- Subjects who received prior chemotherapy (i.e., first-line treatment) or are not receiving any chemotherapy for their non-Hodgkin's (NHL) or Hodgkin's lymphoma (HD) are ineligible.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
West Virginia University Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506
About this study
Official title: A Prospective Clinicopathological Cohort Study of Lymphoproliferative Diseases at Kenyatta National Hospital in Nairobi, Kenya
This study will help researchers learn more about non-Hodgkin's lymphoma and Hodgkin's lymphoma and how it is treated in Kenya. Researchers want to see if having certain viruses like Epstein Barr Virus (EBV), Human Immunodeficiency Virus (HIV), and Kaposi's Sarcoma Herpes Virus (KSHV) affects lymphoma. Patients in Kenya who agree to be in this study will let the resesarchers look at their medical record, follow their normal cancer care, and have blood drawn to look at different proteins and viruses. Researchers would also like to look at part of the original tumor that was taken out of each patient. Some of these samples will be stored at Kenyatta National Hospital and research will be done on them later. This study does not involve any change in treatment, but only allows the study team to follow how a patient in Kenya with lymphoma is treated.
Read the detailed description
Comprehensive prospective cohort study of lymphoproliferative diseases in Nairobi, Kenya.
- Conditions
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Kenya, Epstein Barr Virus (EBV), Human Immunodeficiency Virus (HIV), Kaposi's Sarcoma Herpes Virus (KSHV)
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease, Epstein-Barr Virus Infections, Acquired Immunodeficiency Syndrome
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 |
|---|---|---|
| No treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the spectrum and natural history of lymphoproliferative disorders in Nairobi, Kenya
To determine the spectrum and natural history of lymophoproliferative disorders in Nairobi, Kenya by prospectively recruiting subjects with biopsy-proven malignant lymphoma including non-Hodgkin's and Hodgkin's lymphoma regardless of age, sex and HIV-serostatus (cohort study), who are seen at the Kenyatta National Hospital for treatment.
Measured: 2.5 Years
Secondary outcomes (2)
To perform a comprehensive clinicopathological study in these subjects.
To perform a comprehensive clinicopathological study in these subjects with complete virological, immunophenotypic, and molecular characterization of retrieved tumor tissues and peripheral blood samples for purposes of identifying prognostic and predictive biomarkers of clinical outcome (i.e. treatment response, freedom from disease progression, and overall survival) in which to begin to frame pragmatic, risk-adapted therapeutic interventions suitable for the resource constrained setting in sub-Saharan Africa.
Measured: 2.5 Years
Companion R01 proposal: Clinicopathological Cohort Study of EBV-Associated Lymphomas in Kenya
- Aim 1: Determine the tissue biomarkers of EBV infection in AIDS-related lymphomas (ARL) in Kenya
- Aim 2: Compare the pattern of EBV persistence in patients with EBV+ and EBV- lymphoma
- Aim 3: Determine predictors of treatment outcome in AIDS-related lymphomas (ARL)
Measured: To be submitted next 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
Why it stopped: Protocol not considered a clinical trial for registration purposes; no subjects enrolled to date pending further grant funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- Kenyatta National Hospital
- Responsible party
- Sponsor
- Investigators
- Scot C Remick, MD, Principal investigator, West Virginia UniversityWalter O Mwanda, MD, Principal investigator, Kenyatta National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704742
- Sponsor's protocol ID
- WVU1411
- Status last verified
- Nov 2016
- First submitted
- 3 Oct 2012
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PubMed 21296855World Health Organization. Cancer. Fact Sheet No. 297, February 2011. Available at http://www.who.int/mediacentre/factsheets /fs297/en/index.html. Accessioned March 28, 2011.
World Health Organization. The Global Burden of Disease: 2004 Update. Geneva: WHO, 2008.
Ferlay J, Shin HR, Bray F, Forman D, Mathers C, and Parkin DM. Globocan 2008: cancer incidence and mortality worldwide. Lyon: International Agency for Research on Cancer, 2010. Available at: http://www.iarc/fr/. Accessioned March 28, 2011.
Remick SC. Responding to the global cancer burden through partnerships. In: Am. Soc. Clin. Oncol. Ed. Book 2009; 670-4.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinicopathological Cohort Study of Lymphoproliferative Diseases at Kenyatta National Hospital in Nairobi, Kenya
- ClinicalTrials.gov ID
- NCT01704742
- Acronym / sponsor ID
- WVU1411
- Conditions
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Kenya, Epstein Barr Virus (EBV), Human Immunodeficiency Virus (HIV), Kaposi's Sarcoma Herpes Virus (KSHV)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Protocol not considered a clinical trial for registration purposes; no subjects enrolled to date pending further grant funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- Kenyatta National Hospital
- First posted
- 11 Oct 2012 (estimated)
- 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.
This study will help researchers learn more about non-Hodgkin's lymphoma and Hodgkin's lymphoma and how it is treated in Kenya. Researchers want to see if having certain viruses like Epstein Barr Virus (EBV), Human Immunodeficiency Virus (HIV), and Kaposi's Sarcoma Herpes Virus (KSHV) affects lymphoma. Patients in Kenya who agree to be in this study will let the resesarchers look at their medical record, follow their normal cancer care, and have blood drawn to look at different proteins and viruses. Researchers would also like to look at part of the original tumor that was taken out of each patient. Some of these samples will be stored at Kenyatta National Hospital and research will be done on them later. This study does not involve any change in treatment, but only allows the study team to follow how a patient in Kenya with lymphoma is treated.
Detailed description
Comprehensive prospective cohort study of lymphoproliferative diseases in Nairobi, Kenya.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at Kenyatta National Hospital in Kenya being treated for non-Hodgkin's lymphoma or Hodgkin's lymphoma.
Key inclusion criteria (5 listed)
- All subjects regardless of age, sex or HIV serostatus must have biopsy-proven non-Hodgkin's (NHL), including primary effusion lymphoma, Hodgkin's lymphoma (HD) or other lymphoproliferative disorder (e.g., Castleman's disease) with measurable or evaluable stage I through IV disease.
- [Note: Lymphomas will be categorized on the basis of current WHO classification scheme, but it is recognized that initial pathological categorization at time of study enrollment will more than likely be classified or graded as low-, intermediate-, or high-grade lymphoma by Working Formulation criteria. This is the current standard of practice in Kenya.]
- All subjects must receive some form of systemic chemotherapy. Subjects not receiving chemotherapy of any kind are not eligible. Subjects must not have had any prior chemotherapy for lymphoma.
- Subjects may have received prior radiotherapy for localized stage I or stage II disease that is clearly documented to have progressed beyond initial radiotherapy ports.
- All subjects must give written informed consent to participate on study. In Kenya, a child is considered < 18 years of age and an adult ≥ 18 years of age. All children will have their parental or legal guardian provide consent.. Children between the ages of 7 and < 18 years old should be given the opportunity to provide their assent. For children between the ages of 7 and 11 years old this should be done using the parental consent form assent statement. For children > 11 years old assent should be documented using the IRB approved assent form.
Key exclusion criteria (2 listed)
- Subjects who do not fulfill the criteria as listed in Sections 3.1.1 through 3.1.4 are ineligible.
- Subjects who received prior chemotherapy (i.e., first-line treatment) or are not receiving any chemotherapy for their non-Hodgkin's (NHL) or Hodgkin's lymphoma (HD) are ineligible.
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
To determine the spectrum and natural history of lymphoproliferative disorders in Nairobi, Kenya
Time frame: 2.5 Years
To determine the spectrum and natural history of lymophoproliferative disorders in Nairobi, Kenya by prospectively recruiting subjects with biopsy-proven malignant lymphoma including non-Hodgkin's and Hodgkin's lymphoma regardless of age, sex and HIV-serostatus (cohort study), who are seen at the Kenyatta National Hospital for treatment.
2 secondary outcomes
To perform a comprehensive clinicopathological study in these subjects.
Time frame: 2.5 Years
Companion R01 proposal: Clinicopathological Cohort Study of EBV-Associated Lymphomas in Kenya
Time frame: To be submitted next 6 months to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Background: PubMed 21296855Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
- BackgroundWorld Health Organization. Cancer. Fact Sheet No. 297, February 2011. Available at http://www.who.int/mediacentre/factsheets /fs297/en/index.html. Accessioned March 28, 2011.
- BackgroundWorld Health Organization. The Global Burden of Disease: 2004 Update. Geneva: WHO, 2008.
- BackgroundFerlay J, Shin HR, Bray F, Forman D, Mathers C, and Parkin DM. Globocan 2008: cancer incidence and mortality worldwide. Lyon: International Agency for Research on Cancer, 2010. Available at: http://www.iarc/fr/. Accessioned March 28, 2011.
- BackgroundRemick SC. Responding to the global cancer burden through partnerships. In: Am. Soc. Clin. Oncol. Ed. Book 2009; 670-4.
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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. This study is not recruiting at the moment.
Scot C Remick, MD principal investigator
West Virginia University
Walter O Mwanda, MD principal investigator
Kenyatta National Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma, run by West Virginia University at 2 sites in 2 countries.
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 5 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: withdrawn, as of the sponsor's last update on 8 Nov 2016. 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 United States, Kenya. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To determine the spectrum and natural history of lymphoproliferative disorders in Nairobi, Kenya (time frame: 2.5 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 NCT01704742, which also lists 5 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 8 Nov 2016.