Metabolic DiseaseNCT02890342
Natural History, Physiology, Microbiome and Biochemistry Studies of Propionic Acidemia
An observational study of Metabolic Disease and Propionic Acidemia, run by National Human Genome Research Institute (NHGRI) at 2 sites in United States.
Trial summary
Background: People s bodies need to break down food into the chemicals. These chemicals are used for energy and growth. Some people cannot process all chemicals very well. Too much of some chemicals can cause diseases. One of these diseases is called propionic acidemia (PA). Read more about this study
- Who is it for?
- Ages 1 month to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease, Propionic Acidemia, Organic Acidemia
- How many people
- 1,045 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Nov 2016to 31 Aug 2036
- 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 1 month to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with Propionic Acidemia
Who may be able to join
- Patients 2 years of age or older, of any gender and ethnicity, with propionic acidemia are eligible to enroll in this protocol. Patients diagnosis will be confirmed based on biochemical and/or molecular and enzymatic testing. Participants of any gender and ethnicity over 1 month of age are eligible to enroll remotely for collection of outside records and natural history data. They will be eligible to enroll in the full study for in-person evaluation at 2 years of age.
- Unaffected family members over 1 month of age, of any ethnicity or race, may be included in the study as household controls for microbiome studies and/or for genetic analysis. Studies in unaffected family members may include collection of medical and family history; if necessary completion of physical examination; drawing of blood for research purposes include testing of DNA; collection of stool samples for microbiome studies; collection of dietary history using pen-and-paper or electronic food diary and questionnaires; collection of saliva for metabolite and DNA analysis. In some unaffected family members without a known familial cause of propionic acidemia, exome sequencing or genome sequencing could be performed. Unaffected family members will not receive direct benefit from taking part in the study.
- If a participant becomes pregnant while on study, the participant can remain on study. The only way to learn more about the critical biological differences in those who affected with propionic acidemia who are pregnant is to continue to follow pregnant women on study.
- However, no tests or procedures that are greater then minimal risk will be performed. Affected subjects who are pregnant may undergo procedures as part of their clinical care, including blood draws, genetic studies, and consultations, according to the clinical judgement of the clinical team. However, pregnant participants will be excluded from procedures such as organ tissue collection, stable isotope studies, GFR testing, and brain or cardiac MRI until the pregnancy is concluded.
- Healthy volunteers may be eligible to participate in the study if they are between 12 - 40 years of age, must meet specific BMI criteria (similar to affected individuals studied).
- Patients with propionic acidemia over 1 month of age, of any gender and ethnicity, undergoing a transplantation surgery at Children s Hospital of Pittsburgh, are eligible to participate in the tissue collection arm of the study.
Who cannot join
- The PI/AI may decline to enroll a patient because of poor metabolic control, lack of a primary metabolic/genetics physician, and intercurrent infection are exclusion criteria for this protocol, the likelihood that an acutely ill or poorly controlled patient will enroll will be minimized.
- A subset of participants may be enrolled in the tissue collection part of the study only (i.e. if they are too sick to travel). We can may also arrange limited remote consultation with our research team and NIH consultants, the participants referring physician and the participant/their legal guardian through the telephone or an NIH supported telehealth platform for participants who are unable to safely travel to NIH. This would not replace a study visit but would be used when travel isn t possible due to extenuating circumstances (e.g. pandemic). Participants would be encouraged to follow-up for a more thorough in-person evaluation when they are able to travel to NIH.
- For the healthy volunteers, they will be excluded if they have halitosis, cavities, dental or gingival problems, respiratory diseases (for example, asthma or recent history of COVID19), use tobacco products (for example, cigarette smoking or chewing tobacco), or use electronic nicotine delivery systems (for example, use of e-cigarettes or vaping devices), as this may interfere with accurate measurement of their volatile organic compounds. NIH staff and their family members will be eligible to participate in the healthy volunteer portion of the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
- Recruiting
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
James Squires, MD, MS, 412-692-5180, james.squires2@chp.edu
About this study
Official title: The Natural History, Physiology, Microbiome and Biochemistry Studies of Propionic Acidemia
Background:
People s bodies need to break down food into the chemicals. These chemicals are used for energy and growth. Some people cannot process all chemicals very well. Too much of some chemicals can cause diseases. One of these diseases is called propionic acidemia (PA). People with PA can have problems with growth, learning heart, abdomen, and other organs. Researchers want to better understand how these problems happen.
Read more
Objective:
To learn more about propionic acidemia and the genes that might contribute to it.
Eligibility:
People at least 2 years old with PA who can travel to the clinic
Some unaffected family members
Design:
Participants will have a 3 to 5-day hospital visit every year or every few years. Family members may have just 1 visit.
During the family member visit, they may have:
Medical history
Physical exam
Samples of blood and urine
Questions about diet and a food diary
Doctors and nurses may do additional studies:
Samples of saliva, skin and stool
Fluid from a gastronomy tube, if participants have one
Dental and eye evaluations
A kidney test - a small amount of dye will be injected and blood will be collected.
Consultations with specialists
A test of calories needed at rest. A clear plastic tent is placed over the participant to measure breathing.
Stable isotope study. Participants will take a nonradioactive substance then blow into a bag.
Photos taken of the face and body with underwear on
Ultrasound of the abdomen
Heart tests
Hand x-ray
Brain scan
Participants may have other tests if study doctors recommend them. They will get the results of standard medical tests and genetic tests.
Read the detailed description
Propionic acidemia (PA) is one of the most common inborn errors of organic acid metabolism. Although this disorder is now routinely detected in the immediate neonatal period on the US newborn screen, clinical outcomes are poor despite timely and aggressive medical intervention. Worldwide, the incidence of PA varies widely. The estimated live-birth incidence of PA is 1:243,000 in the US, 1:166,000 in Italy and 1:250,000 in Germany. Affected patients are medically fragile and can suffer from complications such as failure to thrive, intellectual disability, basal ganglia strokes, seizures, cardiomyopathy, cardiac arrhythmias, pancreatitis, impaired gut motility, osteoporosis and hematological complications. The frequency of these complications in the US patients and their precipitants remain poorly understood. Furthermore, current treatment outcomes have continued to demonstrate substantial morbidity and mortality in the patient population. Specific treatments include dietary modification to reduce propiogenic precursor load, levocarnitine to facilitate excretion of propionate, and oral antibiotics to suppress propionogenic gut flora. More recently, solid organ transplantation (liver and/or kidney) has been used to treat PA patients experiencing frequent and severe episodes of metabolic instability. However, optimal transplant strategy and post-transplant management have not been delineated. Several survey-based and retrospective studies describing the natural history of propionic acidemia have been published in the last decade. While these publications added to our understanding of the clinical course of this disease, these studies have not systematically focused on the US population using prospective analysis and reflect largely European experience, where many developed countries do not routinely screen for PA using newborn screen. Thus, the benefits of newborn screening on the PA outcomes require further clarification.
Under proposed NIH protocol, we will prospectively evaluate patients with propionic acidemia with special emphasis on the US population. Typical inpatient admissions and outpatient evaluations will last up to 4-5 days and may involve blood drawing, urine collection, stool collections, genomic studies, ophthalmological examination, cardiology evaluation, radiological procedures, brain and cardiac MRI/MRS, dietary assessment and neurobehavioral evaluation. In some patient s skin biopsies will be pursued.
The study objectives will be to describe the natural history of propionic acidemia in the US patients by delineating the spectrum of phenotypes and querying for genotype, enzymology, microbiome, and phenotype correlations. The population will consist of patients previously evaluated at NIH, physician referrals, and families directed to the study from clinicaltrials.gov, Organic Acidemia Association and Propionic Acidemia Foundation. Patients will be evaluated at the NIH Clinical Center or via telehealth platforms supported by NIH. Outcome measures will largely be descriptive and encompass correlations between clinical, microbiological, biochemical and molecular parameters.
- Conditions
- Metabolic Disease, Propionic Acidemia, Organic Acidemia
- Keywords
- Organic Acidemia, Inborn Errors of Metabolism, Natural History
- Medical subject headings
- Metabolic Diseases, Propionic Acidemia, Metabolism, Inborn Errors
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 |
|---|---|---|
| Affected Patients with Propionic Acidemia | Patients with Propionic Acidemia, standard adult, parental permission | |
| Healthy Volunteers | Healthy Volunteers, standard adult, parental permission | |
| Unaffected Family Members | Unaffected family members |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural history to asess long term complications of Propionic Acidemia
assessing the long term complications of Propionic Acidemia during a week long evaluation with imaging, labs, and consultations.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start29 Nov 2016
- Primary completion31 Aug 2036 (estimated)
- Study completion31 Aug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseaseStudies 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
- Prospective
- Enrolment
- 1,045 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Charles P Venditti, M.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890342
- Sponsor's protocol ID
- 160156
- Other IDs
- 16-HG-0156
- Status last verified
- 3 Sep 2026
- First submitted
- 3 Sep 2016
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study is observational natural history study that is ongoing with no defined endpoints
Publications
Shchelochkov OA, Davies H, Mohney RP, Hatch A, Birch O, Ferry S, Van Ryzin C, Hall C, McCoy S, Vockley J, Kuo MJM, Manoli I, Sloan JL, Venditti CP. Breath biopsy in inborn errors of metabolism: A proof-of-principle study in propionic acidemia. Mol Genet Metab. 2025 Mar;144(3):109005. doi: 10.1016/j.ymgme.2024.109005. Epub 2024 Dec 21.
PubMed 39787887Shchelochkov OA, Manoli I, Juneau P, Sloan JL, Ferry S, Myles J, Schoenfeld M, Pass A, McCoy S, Van Ryzin C, Wenger O, Levin M, Zein W, Huryn L, Snow J, Chlebowski C, Thurm A, Kopp JB, Chen KY, Venditti CP. Severity modeling of propionic acidemia using clinical and laboratory biomarkers. Genet Med. 2021 Aug;23(8):1534-1542. doi: 10.1038/s41436-021-01173-2. Epub 2021 May 18.
PubMed 34007002Shchelochkov OA, Manoli I, Sloan JL, Ferry S, Pass A, Van Ryzin C, Myles J, Schoenfeld M, McGuire P, Rosing DR, Levin MD, Kopp JB, Venditti CP. Chronic kidney disease in propionic acidemia. Genet Med. 2019 Dec;21(12):2830-2835. doi: 10.1038/s41436-019-0593-z. Epub 2019 Jun 28.
PubMed 31249402
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History, Physiology, Microbiome and Biochemistry Studies of Propionic Acidemia
- ClinicalTrials.gov ID
- NCT02890342
- Acronym / sponsor ID
- 160156
- Conditions
- Metabolic Disease, Propionic Acidemia, Organic Acidemia
- Keywords
- Organic Acidemia, Inborn Errors of Metabolism, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,045 participants (estimated)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 31 Aug 2036 (estimated)
- Study completion
- 31 Aug 2036 (estimated)
- First posted
- 7 Sep 2016 (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.
Background:
People s bodies need to break down food into the chemicals. These chemicals are used for energy and growth. Some people cannot process all chemicals very well. Too much of some chemicals can cause diseases. One of these diseases is called propionic acidemia (PA). People with PA can have problems with growth, learning heart, abdomen, and other organs. Researchers want to better understand how these problems happen.
Objective:
To learn more about propionic acidemia and the genes that might contribute to it.
Eligibility:
People at least 2 years old with PA who can travel to the clinic
Some unaffected family members
Design:
Participants will have a 3 to 5-day hospital visit every year or every few years. Family members may have just 1 visit.
During the family member visit, they may have:
Medical history
Physical exam
Samples of blood and urine
Questions about diet and a food diary
Doctors and nurses may do additional studies:
Samples of saliva, skin and stool
Fluid from a gastronomy tube, if participants have one
Dental and eye evaluations
A kidney test - a small amount of dye will be injected and blood will be collected.
Consultations with specialists
A test of calories needed at rest. A clear plastic tent is placed over the participant to measure breathing.
Stable isotope study. Participants will take a nonradioactive substance then blow into a bag.
Photos taken of the face and body with underwear on
Ultrasound of the abdomen
Heart tests
Hand x-ray
Brain scan
Participants may have other tests if study doctors recommend them. They will get the results of standard medical tests and genetic tests.
Detailed description
Propionic acidemia (PA) is one of the most common inborn errors of organic acid metabolism. Although this disorder is now routinely detected in the immediate neonatal period on the US newborn screen, clinical outcomes are poor despite timely and aggressive medical intervention. Worldwide, the incidence of PA varies widely. The estimated live-birth incidence of PA is 1:243,000 in the US, 1:166,000 in Italy and 1:250,000 in Germany. Affected patients are medically fragile and can suffer from complications such as failure to thrive, intellectual disability, basal ganglia strokes, seizures, cardiomyopathy, cardiac arrhythmias, pancreatitis, impaired gut motility, osteoporosis and hematological complications. The frequency of these complications in the US patients and their precipitants remain poorly understood. Furthermore, current treatment outcomes have continued to demonstrate substantial morbidity and mortality in the patient population. Specific treatments include dietary modification to reduce propiogenic precursor load, levocarnitine to facilitate excretion of propionate, and oral antibiotics to suppress propionogenic gut flora. More recently, solid organ transplantation (liver and/or kidney) has been used to treat PA patients experiencing frequent and severe episodes of metabolic instability. However, optimal transplant strategy and post-transplant management have not been delineated. Several survey-based and retrospective studies describing the natural history of propionic acidemia have been published in the last decade. While these publications added to our understanding of the clinical course of this disease, these studies have not systematically focused on the US population using prospective analysis and reflect largely European experience, where many developed countries do not routinely screen for PA using newborn screen. Thus, the benefits of newborn screening on the PA outcomes require further clarification.
Under proposed NIH protocol, we will prospectively evaluate patients with propionic acidemia with special emphasis on the US population. Typical inpatient admissions and outpatient evaluations will last up to 4-5 days and may involve blood drawing, urine collection, stool collections, genomic studies, ophthalmological examination, cardiology evaluation, radiological procedures, brain and cardiac MRI/MRS, dietary assessment and neurobehavioral evaluation. In some patient s skin biopsies will be pursued.
The study objectives will be to describe the natural history of propionic acidemia in the US patients by delineating the spectrum of phenotypes and querying for genotype, enzymology, microbiome, and phenotype correlations. The population will consist of patients previously evaluated at NIH, physician referrals, and families directed to the study from clinicaltrials.gov, Organic Acidemia Association and Propionic Acidemia Foundation. Patients will be evaluated at the NIH Clinical Center or via telehealth platforms supported by NIH. Outcome measures will largely be descriptive and encompass correlations between clinical, microbiological, biochemical and molecular parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Affected Patients with Propionic Acidemia | – | –Patients with Propionic Acidemia, standard adult, parental permission |
| Healthy Volunteers | – | –Healthy Volunteers, standard adult, parental permission |
| Unaffected Family Members | – | –Unaffected family members |
Who may qualify
- Ages
- 1 month to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Propionic Acidemia
Key inclusion criteria (6 listed)
- Patients 2 years of age or older, of any gender and ethnicity, with propionic acidemia are eligible to enroll in this protocol. Patients diagnosis will be confirmed based on biochemical and/or molecular and enzymatic testing. Participants of any gender and ethnicity over 1 month of age are eligible to enroll remotely for collection of outside records and natural history data. They will be eligible to enroll in the full study for in-person evaluation at 2 years of age.
- Unaffected family members over 1 month of age, of any ethnicity or race, may be included in the study as household controls for microbiome studies and/or for genetic analysis. Studies in unaffected family members may include collection of medical and family history; if necessary completion of physical examination; drawing of blood for research purposes include testing of DNA; collection of stool samples for microbiome studies; collection of dietary history using pen-and-paper or electronic food diary and questionnaires; collection of saliva for metabolite and DNA analysis. In some unaffected family members without a known familial cause of propionic acidemia, exome sequencing or genome sequencing could be performed. Unaffected family members will not receive direct benefit from taking part in the study.
- If a participant becomes pregnant while on study, the participant can remain on study. The only way to learn more about the critical biological differences in those who affected with propionic acidemia who are pregnant is to continue to follow pregnant women on study.
- However, no tests or procedures that are greater then minimal risk will be performed. Affected subjects who are pregnant may undergo procedures as part of their clinical care, including blood draws, genetic studies, and consultations, according to the clinical judgement of the clinical team. However, pregnant participants will be excluded from procedures such as organ tissue collection, stable isotope studies, GFR testing, and brain or cardiac MRI until the pregnancy is concluded.
- Healthy volunteers may be eligible to participate in the study if they are between 12 - 40 years of age, must meet specific BMI criteria (similar to affected individuals studied).
Key exclusion criteria (3 listed)
- The PI/AI may decline to enroll a patient because of poor metabolic control, lack of a primary metabolic/genetics physician, and intercurrent infection are exclusion criteria for this protocol, the likelihood that an acutely ill or poorly controlled patient will enroll will be minimized.
- A subset of participants may be enrolled in the tissue collection part of the study only (i.e. if they are too sick to travel). We can may also arrange limited remote consultation with our research team and NIH consultants, the participants referring physician and the participant/their legal guardian through the telephone or an NIH supported telehealth platform for participants who are unable to safely travel to NIH. This would not replace a study visit but would be used when travel isn t possible due to extenuating circumstances (e.g. pandemic). Participants would be encouraged to follow-up for a more thorough in-person evaluation when they are able to travel to NIH.
- For the healthy volunteers, they will be excluded if they have halitosis, cavities, dental or gingival problems, respiratory diseases (for example, asthma or recent history of COVID19), use tobacco products (for example, cigarette smoking or chewing tobacco), or use electronic nicotine delivery systems (for example, use of e-cigarettes or vaping devices), as this may interfere with accurate measurement of their volatile organic compounds. NIH staff and their family members will be eligible to participate in the healthy volunteer portion of the study.
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
Natural history to asess long term complications of Propionic Acidemia
Time frame: Ongoing
assessing the long term complications of Propionic Acidemia during a week long evaluation with imaging, labs, and consultations.
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 5 Nov 2026.
- Derived from this study: PubMed 39787887Shchelochkov OA, Davies H, Mohney RP, Hatch A, Birch O, Ferry S, Van Ryzin C, Hall C, McCoy S, Vockley J, Kuo MJM, Manoli I, Sloan JL, Venditti CP. Breath biopsy in inborn errors of metabolism: A proof-of-principle study in propionic acidemia. Mol Genet Metab. 2025 Mar;144(3):109005. doi: 10.1016/j.ymgme.2024.109005. Epub 2024 Dec 21.
- Derived from this study: PubMed 34007002Shchelochkov OA, Manoli I, Juneau P, Sloan JL, Ferry S, Myles J, Schoenfeld M, Pass A, McCoy S, Van Ryzin C, Wenger O, Levin M, Zein W, Huryn L, Snow J, Chlebowski C, Thurm A, Kopp JB, Chen KY, Venditti CP. Severity modeling of propionic acidemia using clinical and laboratory biomarkers. Genet Med. 2021 Aug;23(8):1534-1542. doi: 10.1038/s41436-021-01173-2. Epub 2021 May 18.
- Derived from this study: PubMed 31249402Shchelochkov OA, Manoli I, Sloan JL, Ferry S, Pass A, Van Ryzin C, Myles J, Schoenfeld M, McGuire P, Rosing DR, Levin MD, Kopp JB, Venditti CP. Chronic kidney disease in propionic acidemia. Genet Med. 2019 Dec;21(12):2830-2835. doi: 10.1038/s41436-019-0593-z. Epub 2019 Jun 28.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Study is observational natural history study that is ongoing with no defined endpoints
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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.
Charles P Venditti, M.D. principal investigator
National Human Genome Research Institute (NHGRI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Disease and Propionic Acidemia, run by National Human Genome Research Institute (NHGRI) at 2 sites 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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. 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?
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 Susan C Ferry, R.N. ((301) 496-6213, pastudy@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural history to asess long term complications of Propionic Acidemia (time frame: Ongoing). 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 NCT02890342, which also lists 3 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 5 Nov 2026.