LymphomaNCT00001852
Natural History of Salivary Gland Dysfunction and Sjogren's Syndrome
An observational study of Lymphoma and Salivary Gland Disease, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
This study will follow patients with salivary gland dysfunction to identify the long-term course of this disorder and its effects on the mouth, oral function, and overall health. Saliva is important in maintaining oral health and comfort. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphoma, Salivary Gland Disease, Sjogren's Syndrome
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 1999to 29 Nov 2017
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects.
- All subjects will have first participated in screening protocol 84-D-0056 to confirm their diagnosis and assess salivary function.
- Subjects must have dry mouth symptoms (xerostomia) and a diagnosis of primary or secondary SS, incomplete SS, or radiation-induced salivary gland dysfunction (as determined in protocol 84-D-0056).
- Diagnostic criteria for SS are the American-European Consensus Group Classification Criteria: For primary Sjogren s syndrome, any 4 of the 6 criteria, must include item IV (Histopathology) or VI (Auto-antibodies) or any 3 of the 4 objective criteria (III, IV, V, VI). For secondary Sjogren s syndrome, must have established connective tissue disease, one symptom (I or II) plus 2 of the 3 objective criteria (III, IV, VI).
- Ocular symptoms (at least one)
- Daily persistent dry eyes for greater than 3 months?
Show all 24Show fewer
- Recurrent sensation of sand or gravel in the eyes?
- Use of tear substitutes greater than 3 x/day?
- Oral symptoms (at least one)
- Daily feeling of dry Mouth greater than 3 months
- Recurrent or persistently swollen salivary glands as an adult?
- Frequently drink liquids to aid in swallowing dry foods?
- Ocular signs (at least one)
- Schirmer s test, (without anesthesia) greater than or equal to 5mm/5 minutes
- Positive vital dye staining (van Bijsterveld greater than or equal to 4)
- Histopathology: Lip biopsy showing focal lymphocytic sialadenitis (focus score greater or equal to 1 per 4mm squared)
- Oral signs (at least one)
- Unstimulated whole salivary flow (greater or equal to 1.5 ml in 15 minutes)
- Abnormal parotid sialography
- Abnormal salivary scintigraphy
- Auto-antibodies (at least one)
- Anti-SSA (Ro) or Anti-SSB (La)
- Age 18 years or older.
- Ability to give informed consent.
Who cannot join
- Past head and neck radiation treatment
- Hepatitis C infection
- Acquired Immunodeficiency Syndrome (AIDS)
- Pre-existing lymphoma
- Sarcoidosis
- Graft versus host disease
Show all 15Show fewer
- Current use of anticholinergic drugs
- Failure to complete evaluation procedures as specified in 84-D-0056.
- Diagnosis of drug-related xerostomia.
- Age less than 4 years.
- There are no exclusions based on gender, race, or ethnicity. Salivary gland dysfunction is uncommon in children and exceedingly rare in those less than 4 years old. Additionally, the evaluation method described in the protocol cannot be used in this age group.
- ULTRASOUND GUIDED CORE NEEDLE BIOPSY OF THE PAROTID GLAND
- Adult subjects already enrolled in this protocol and healthy volunteers will be eligible for this research procedure if they fulfill the criteria below and sign the parotid biopsy consent form. Healthy volunteers will be recruited only for the ultrasound guided core needle biospy of the parotid gland. They will sign the parotid biopsy consent form only.
- History of bleeding diathesis or the current use of anticoagulants.
- Any uncontrolled or severe chronic disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
This study will follow patients with salivary gland dysfunction to identify the long-term course of this disorder and its effects on the mouth, oral function, and overall health. Saliva is important in maintaining oral health and comfort. It moistens the mouth, lubricates food for easier swallowing, provides enzymes needed to begin the digestive process and promotes repair and cleansing of soft tissues of the mouth. Decreased salivary production or changes in salivary composition may affect oral and systemic health and cause an increase in tooth decay.
Patients 4 years of age and older with dry mouth symptoms and a diagnosis of primary, secondary or incomplete Sj(SqrRoot)(Delta)gren s syndrome or salivary gland dysfunction due to radiation may be eligible for this study. Candidates will be screened with a complete medical and dental history and blood and saliva tests. Some patients will have a biopsy of the minor salivary glands, usually from the lower lip, to confirm or rule out the diagnosis of Sj(SqrRoot)(Delta)gren s syndrome and determine the extent of changes in the salivary glands. (A biopsy is the surgical removal of a small piece of tissue for laboratory examination.) The ability to taste and smell may also be evaluated, and patients may have an ultrasound examination of their swallowing function.
Read more
Participants will have a general oral examination of the teeth and soft tissues of the mouth, general physical examination, eye examination and blood tests and will fill out a questionnaire on oral health and function. In addition, they will have the following tests and procedures:
- Identification of possible fungal infection Patients rinse their mouth with 2 teaspoons of a salt-water solution and spit it in a sterile container for laboratory examination. If a fungal infection is detected, treatment will be offered.
- Unstimulated salivary function assessment Saliva production is measured by collecting saliva samples through small suction cups connected to collection tubes over the salivary gland ducts in the mouth.
- Stimulated salivary function assessment A sour-tasting liquid (2% citric acid) is applied to the top and sides of the tongue at 30-second intervals to stimulation saliva production while saliva is collected using the procedure described above.
- Identification of markers of precancerous lesions The salivary gland biopsy done at the screening evaluation (or from outside sources) is examined for markers of precancerous lesions, as about 5 percent of patients with Sj(SqrRoot)(Delta)gren's syndrome develop a tumor called Non-Hodgkin s lymphoma. In some cases, the minor salivary glands may be re-biopsied a few years after the screening biopsy.
Patients will be followed once a year with a comprehensive history and physical examination, eye examination, full oral examination, salivary function assessment and questionnaires about signs and symptoms of salivary gland dysfunction.
Read the detailed description
Saliva plays a major role in maintaining oral health and comfort. Saliva is needed to moisten the mouth, to lubricate food for easier swallowing, to protect oral hard and soft tissues, to modulate oral microbial populations, to provide enzymes necessary to begin food breakdown for digestion, and to promote soft tissue repair and oral cleansing. Therefore, salivary dysfunction may result in numerous clinical conditions affecting oral and systemic health, comfort and quality of life. In particular, we will focus on individuals with Sj(SqrRoot)(Delta)gren's syndrome, an autoimmune exocrinopathy that primarily affects the salivary and lacrimal glands. A number of unanswered questions remain concerning salivary involvement in this disorder. These include the rate of progression of secretory dysfunction, and related oral and systemic complications associated with xerostomia in autoimmune and non-autoimmune diseases, and B-cell dysregulation. Also, more precise estimates of the incidence of the lymphoma development are needed.
The purpose of this study is :1) to allow careful follow-up of patients with defined salivary gland alterations so that the long term course and effects of Sj(SqrRoot)(Delta)gren's syndrome (SS) on the oral cavity and systemic health in SS may be delineated; 2) to follow the development and progression of B-cell dysregulation in SS; 3) to follow subjects to establish whether those initially manifesting incomplete criteria for SS progress toward fully meeting the criteria.; 4) to refine diagnostic tests for SS, and to determine whether those subjects who meet the criteria for SS continue to do so; and 5) to develop intermediary outcome measures for SS based on long term outcomes (loss of tears and loss of stimulated salivary flow).
Patients will return every two years from the baseline visit for a full oral examination, salivary function assessment, clinical laboratory studies, and questionnaires concerning signs and symptoms of salivary gland dysfunction. These individuals will be patients with Sj(SqrRoot)(Delta)gren's syndrome (SS), incomplete SS (patients who have some, but not all of the criteria for SS) or radiation-induced salivary gland hypofunction. We anticipate that many of these patients will also participate in therapeutic trials conducted within the branch.
- Conditions
- Lymphoma, Salivary Gland Disease, Sjogren's Syndrome, Xerostomia
- Keywords
- Xerostomia, Oral Dryness, Salivary Function
- Medical subject headings
- Lymphoma, Salivary Gland Diseases, Sjogren's Syndrome, Xerostomia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start9 Apr 1999
- Study completion29 Nov 2017
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 LymphomaStudies 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
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ilias G Alevizos, D.M.D., Principal investigator, National Institute of Dental and Craniofacial Research (NIDCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001852
- Sponsor's protocol ID
- 990070
- Other IDs
- 99-D-0070
- Status last verified
- 29 Nov 2017
- First submitted
- 3 Nov 1999
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Anaya JM, Ogawa N, Talal N. Sjogren's syndrome in childhood. J Rheumatol. 1995 Jun;22(6):1152-8.
PubMed 7674246Andonopoulos AP, Tiniakou M, Melachrinou M, Sfountouris H, Bounas A, Zervas C, Zoumbos NC. Sjogren's syndrome in patients with newly diagnosed untreated non-Hodgkin's lymphoma. Rev Rhum Engl Ed. 1997 May;64(5):287-92.
PubMed 9190001Atkinson JC, Travis WD, Slocum L, Ebbs WL, Fox PC. Serum anti-SS-B/La and IgA rheumatoid factor are markers of salivary gland disease activity in primary Sjogren's syndrome. Arthritis Rheum. 1992 Nov;35(11):1368-72. doi: 10.1002/art.1780351119.
PubMed 1445455Alevizos I, Alexander S, Turner RJ, Illei GG. MicroRNA expression profiles as biomarkers of minor salivary gland inflammation and dysfunction in Sjogren's syndrome. Arthritis Rheum. 2011 Feb;63(2):535-44. doi: 10.1002/art.30131.
PubMed 21280008
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Salivary Gland Dysfunction and Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT00001852
- Acronym / sponsor ID
- 990070
- Conditions
- Lymphoma, Salivary Gland Disease, Sjogren's Syndrome, Xerostomia
- Keywords
- Xerostomia, Oral Dryness, Salivary Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- 9 Apr 1999
- Study completion
- 29 Nov 2017
- First posted
- 4 Nov 1999 (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 follow patients with salivary gland dysfunction to identify the long-term course of this disorder and its effects on the mouth, oral function, and overall health. Saliva is important in maintaining oral health and comfort. It moistens the mouth, lubricates food for easier swallowing, provides enzymes needed to begin the digestive process and promotes repair and cleansing of soft tissues of the mouth. Decreased salivary production or changes in salivary composition may affect oral and systemic health and cause an increase in tooth decay.
Patients 4 years of age and older with dry mouth symptoms and a diagnosis of primary, secondary or incomplete Sj(SqrRoot)(Delta)gren s syndrome or salivary gland dysfunction due to radiation may be eligible for this study. Candidates will be screened with a complete medical and dental history and blood and saliva tests. Some patients will have a biopsy of the minor salivary glands, usually from the lower lip, to confirm or rule out the diagnosis of Sj(SqrRoot)(Delta)gren s syndrome and determine the extent of changes in the salivary glands. (A biopsy is the surgical removal of a small piece of tissue for laboratory examination.) The ability to taste and smell may also be evaluated, and patients may have an ultrasound examination of their swallowing function.
Participants will have a general oral examination of the teeth and soft tissues of the mouth, general physical examination, eye examination and blood tests and will fill out a questionnaire on oral health and function. In addition, they will have the following tests and procedures:
- Identification of possible fungal infection Patients rinse their mouth with 2 teaspoons of a salt-water solution and spit it in a sterile container for laboratory examination. If a fungal infection is detected, treatment will be offered.
- Unstimulated salivary function assessment Saliva production is measured by collecting saliva samples through small suction cups connected to collection tubes over the salivary gland ducts in the mouth.
- Stimulated salivary function assessment A sour-tasting liquid (2% citric acid) is applied to the top and sides of the tongue at 30-second intervals to stimulation saliva production while saliva is collected using the procedure described above.
- Identification of markers of precancerous lesions The salivary gland biopsy done at the screening evaluation (or from outside sources) is examined for markers of precancerous lesions, as about 5 percent of patients with Sj(SqrRoot)(Delta)gren's syndrome develop a tumor called Non-Hodgkin s lymphoma. In some cases, the minor salivary glands may be re-biopsied a few years after the screening biopsy.
Patients will be followed once a year with a comprehensive history and physical examination, eye examination, full oral examination, salivary function assessment and questionnaires about signs and symptoms of salivary gland dysfunction.
Detailed description
Saliva plays a major role in maintaining oral health and comfort. Saliva is needed to moisten the mouth, to lubricate food for easier swallowing, to protect oral hard and soft tissues, to modulate oral microbial populations, to provide enzymes necessary to begin food breakdown for digestion, and to promote soft tissue repair and oral cleansing. Therefore, salivary dysfunction may result in numerous clinical conditions affecting oral and systemic health, comfort and quality of life. In particular, we will focus on individuals with Sj(SqrRoot)(Delta)gren's syndrome, an autoimmune exocrinopathy that primarily affects the salivary and lacrimal glands. A number of unanswered questions remain concerning salivary involvement in this disorder. These include the rate of progression of secretory dysfunction, and related oral and systemic complications associated with xerostomia in autoimmune and non-autoimmune diseases, and B-cell dysregulation. Also, more precise estimates of the incidence of the lymphoma development are needed.
The purpose of this study is :1) to allow careful follow-up of patients with defined salivary gland alterations so that the long term course and effects of Sj(SqrRoot)(Delta)gren's syndrome (SS) on the oral cavity and systemic health in SS may be delineated; 2) to follow the development and progression of B-cell dysregulation in SS; 3) to follow subjects to establish whether those initially manifesting incomplete criteria for SS progress toward fully meeting the criteria.; 4) to refine diagnostic tests for SS, and to determine whether those subjects who meet the criteria for SS continue to do so; and 5) to develop intermediary outcome measures for SS based on long term outcomes (loss of tears and loss of stimulated salivary flow).
Patients will return every two years from the baseline visit for a full oral examination, salivary function assessment, clinical laboratory studies, and questionnaires concerning signs and symptoms of salivary gland dysfunction. These individuals will be patients with Sj(SqrRoot)(Delta)gren's syndrome (SS), incomplete SS (patients who have some, but not all of the criteria for SS) or radiation-induced salivary gland hypofunction. We anticipate that many of these patients will also participate in therapeutic trials conducted within the branch.
Study design
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (24 listed)
- Male and female subjects.
- All subjects will have first participated in screening protocol 84-D-0056 to confirm their diagnosis and assess salivary function.
- Subjects must have dry mouth symptoms (xerostomia) and a diagnosis of primary or secondary SS, incomplete SS, or radiation-induced salivary gland dysfunction (as determined in protocol 84-D-0056).
- Diagnostic criteria for SS are the American-European Consensus Group Classification Criteria: For primary Sjogren s syndrome, any 4 of the 6 criteria, must include item IV (Histopathology) or VI (Auto-antibodies) or any 3 of the 4 objective criteria (III, IV, V, VI). For secondary Sjogren s syndrome, must have established connective tissue disease, one symptom (I or II) plus 2 of the 3 objective criteria (III, IV, VI).
- Ocular symptoms (at least one)
Key exclusion criteria (15 listed)
- Past head and neck radiation treatment
- Hepatitis C infection
- Acquired Immunodeficiency Syndrome (AIDS)
- Pre-existing lymphoma
- Sarcoidosis
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 7674246Anaya JM, Ogawa N, Talal N. Sjogren's syndrome in childhood. J Rheumatol. 1995 Jun;22(6):1152-8.
- Background: PubMed 9190001Andonopoulos AP, Tiniakou M, Melachrinou M, Sfountouris H, Bounas A, Zervas C, Zoumbos NC. Sjogren's syndrome in patients with newly diagnosed untreated non-Hodgkin's lymphoma. Rev Rhum Engl Ed. 1997 May;64(5):287-92.
- Background: PubMed 1445455Atkinson JC, Travis WD, Slocum L, Ebbs WL, Fox PC. Serum anti-SS-B/La and IgA rheumatoid factor are markers of salivary gland disease activity in primary Sjogren's syndrome. Arthritis Rheum. 1992 Nov;35(11):1368-72. doi: 10.1002/art.1780351119.
- Derived from this study: PubMed 21280008Alevizos I, Alexander S, Turner RJ, Illei GG. MicroRNA expression profiles as biomarkers of minor salivary gland inflammation and dysfunction in Sjogren's syndrome. Arthritis Rheum. 2011 Feb;63(2):535-44. doi: 10.1002/art.30131.
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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.
Ilias G Alevizos, D.M.D. principal investigator
National Institute of Dental and Craniofacial Research (NIDCR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Salivary Gland Disease, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
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 24 inclusion and 15 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001852, 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 17 Dec 2019.