Papillary Thyroid MicrocarcinomaNCT04376203
Microbiome and Papillary Thyroid Microcarcinoma
An observational study of Papillary Thyroid Microcarcinoma and Microbiome, run by University of Ioannina.
Trial summary
It has been shown that gut microbiome and microbiome metabolism can regulate or control the initiation of a cancer process. To the best of the investigators knowledge, no study has directly shown the relationship of the thyroid microcarcinoma to the human microbiome. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Papillary Thyroid Microcarcinoma, Microbiome
- What is being tested?
- Thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 27 Jul 2020to 30 May 2023
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients with indication for surgery for thyroid disease
Who may be able to join
- Patients who are going to have surgery for some thyroid disease, benign or malignant
Who cannot join
- Recent, less than 3 months, infection of any system
- Receiving antibiotic or antiviral medication in the previous trimester
- Patient with chronic virus or bacterial infection
- Patient with dermatological disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: What is the Relation of Microbiome to Papillary Thyroid Microcarcinoma Development?
It has been shown that gut microbiome and microbiome metabolism can regulate or control the initiation of a cancer process. To the best of the investigators knowledge, no study has directly shown the relationship of the thyroid microcarcinoma to the human microbiome. In this work, the aim is to detect the microbiome in peripheral blood in a patient with a thyroid gland carcinoma, and to correlate it with the disease, compared to the microbiome of a group of patients who did not find another thyroid gland carcinoma
Read the detailed description
Measurements of biological markers and tumor cell motility may be useful in predicting early whether a papillary thyroid microcarcinoma (PTMC) will develop to invasive carcinoma. Ideally, patients at high risk of progression may undergo immediate surgery instead of active surveillance and those with a very low likelihood of tumor progression may be included in an active surveillance protocol. Future research should focus on the development of new predictive early markers of papillary thyroid carcinoma during patient follow-up. From the above, it is clear the need to develop a new marker that raises the suspicion of possible thyroid microcarcinoma, if it is not preoperatively detected by the needle biopsy method and the patient has the indication for surgery for another benign thyroid disease. To date, there are no absolute biological and clinical parameters distinguishing a low risk from a high risk PTMC. If the fine needle aspiration shows stage V and VI Bethesda classification, and there is a high suspicion of PTMC, then questions such as the extent of the surgery, lobectomy or total thyroidectomy are beginning to be raised. The next dilemma is lymphadenectomy. The dilemma is greater if there are enlarged cervical lymph nodes (diameter over 1 cm in diameter of the small axis) and subsequently micromestases are confirmed. Another entity is when the cervical lymph nodes are not pathologically enlarged. This clinical situation is often emphasized as 60-80% of PTMC patients have metastases. By correlating a possible difference in the microbiome of a participants peripheral blood preoperatively, together with the imaging data, there may have been another marker of early PTMC detection and patient management planning respectively.
- Conditions
- Papillary Thyroid Microcarcinoma, Microbiome
- Being tested
- Thyroidectomy
- Keywords
- Microbiome, Papillary Thyroid Microcarcinoma
- Medical subject headings
- Papillary Thyroid Microcarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyroidectomyProcedure or surgery
Typical Thyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| Control | any patient with indications for thyroidectomy other than confirmed preoperative cancer Receives: Procedure: Thyroidectomy | |
| Thyroid microcarcinoma | either preoperative detection or random finding after thyroidectomy of another indication. Receives: Procedure: Thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of microbiome in peripheral blood sample of a patient with papillary thyroid microcarcinoma
Microbiome in a sample of peripheral blood in a patient with PTMC and to correlate it with the disease as a diagnostic marker compared to patients without any type of thyroid cancer.
Measured: preoperatively periferal blood collection, perioperatively periferal blood colection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start27 Jul 2020 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Papillary Thyroid MicrocarcinomaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefanos Stefanou, University of Ioannina
- Investigators
- KONSTANTINOS VLACHOS, Associate Professor of Surgery, Study chair, University of IoanninaIOANNIS KOUTELIDAKIS, Associate Professor of Surgery, Study chair, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376203
- Sponsor's protocol ID
- Endocrine surgery Unit UOI 1
- Status last verified
- Jun 2020
- First submitted
- 2 May 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data
Publications
Caporaso JG, Lauber CL, Costello EK, Berg-Lyons D, Gonzalez A, Stombaugh J, Knights D, Gajer P, Ravel J, Fierer N, Gordon JI, Knight R. Moving pictures of the human microbiome. Genome Biol. 2011;12(5):R50. doi: 10.1186/gb-2011-12-5-r50.
PubMed 21624126Choi JB, Lee WK, Lee SG, Ryu H, Lee CR, Kang SW, Jeong JJ, Nam KH, Lee EJ, Chung WY, Jo YS, Lee J. Long-term oncologic outcomes of papillary thyroid microcarcinoma according to the presence of clinically apparent lymph node metastasis: a large retrospective analysis of 5,348 patients. Cancer Manag Res. 2018 Aug 27;10:2883-2891. doi: 10.2147/CMAR.S173853. eCollection 2018.
PubMed 30214283David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
PubMed 24336217Feng J, Zhao F, Sun J, Lin B, Zhao L, Liu Y, Jin Y, Li S, Li A, Wei Y. Alterations in the gut microbiota and metabolite profiles of thyroid carcinoma patients. Int J Cancer. 2019 Jun 1;144(11):2728-2745. doi: 10.1002/ijc.32007. Epub 2018 Dec 24.
PubMed 30565661Frank DN, St Amand AL, Feldman RA, Boedeker EC, Harpaz N, Pace NR. Molecular-phylogenetic characterization of microbial community imbalances in human inflammatory bowel diseases. Proc Natl Acad Sci U S A. 2007 Aug 21;104(34):13780-5. doi: 10.1073/pnas.0706625104. Epub 2007 Aug 15.
PubMed 17699621Gevers D, Kugathasan S, Denson LA, Vazquez-Baeza Y, Van Treuren W, Ren B, Schwager E, Knights D, Song SJ, Yassour M, Morgan XC, Kostic AD, Luo C, Gonzalez A, McDonald D, Haberman Y, Walters T, Baker S, Rosh J, Stephens M, Heyman M, Markowitz J, Baldassano R, Griffiths A, Sylvester F, Mack D, Kim S, Crandall W, Hyams J, Huttenhower C, Knight R, Xavier RJ. The treatment-naive microbiome in new-onset Crohn's disease. Cell Host Microbe. 2014 Mar 12;15(3):382-392. doi: 10.1016/j.chom.2014.02.005.
PubMed 24629344Grice EA, Segre JA. The skin microbiome. Nat Rev Microbiol. 2011 Apr;9(4):244-53. doi: 10.1038/nrmicro2537.
PubMed 21407241Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
PubMed 19478181Hannigan GD, Meisel JS, Tyldsley AS, Zheng Q, Hodkinson BP, SanMiguel AJ, Minot S, Bushman FD, Grice EA. The human skin double-stranded DNA virome: topographical and temporal diversity, genetic enrichment, and dynamic associations with the host microbiome. mBio. 2015 Oct 20;6(5):e01578-15. doi: 10.1128/mBio.01578-15.
PubMed 26489866Hedinger C, Williams ED, Sobin LH. The WHO histological classification of thyroid tumors: a commentary on the second edition. Cancer. 1989 Mar 1;63(5):908-11. doi: 10.1002/1097-0142(19890301)63:53.0.co;2-i.
PubMed 2914297Ishaq HM, Mohammad IS, Shahzad M, Ma C, Raza MA, Wu X, Guo H, Shi P, Xu J. Molecular Alteration Analysis of Human Gut Microbial Composition in Graves' disease Patients. Int J Biol Sci. 2018 Sep 7;14(11):1558-1570. doi: 10.7150/ijbs.24151. eCollection 2018.
PubMed 30263008Kaliszewski K, Diakowska D, Wojtczak B, Forkasiewicz Z, Pupka D, Nowak L, Rudnicki J. Which papillary thyroid microcarcinoma should be treated as "true cancer" and which as "precancer"? World J Surg Oncol. 2019 May 31;17(1):91. doi: 10.1186/s12957-019-1638-0.
PubMed 31146753Kasaikina MV, Kravtsova MA, Lee BC, Seravalli J, Peterson DA, Walter J, Legge R, Benson AK, Hatfield DL, Gladyshev VN. Dietary selenium affects host selenoproteome expression by influencing the gut microbiota. FASEB J. 2011 Jul;25(7):2492-9. doi: 10.1096/fj.11-181990. Epub 2011 Apr 14.
PubMed 21493887Koenig JE, Spor A, Scalfone N, Fricker AD, Stombaugh J, Knight R, Angenent LT, Ley RE. Succession of microbial consortia in the developing infant gut microbiome. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4578-85. doi: 10.1073/pnas.1000081107. Epub 2010 Jul 28.
PubMed 20668239Kostic AD, Chun E, Robertson L, Glickman JN, Gallini CA, Michaud M, Clancy TE, Chung DC, Lochhead P, Hold GL, El-Omar EM, Brenner D, Fuchs CS, Meyerson M, Garrett WS. Fusobacterium nucleatum potentiates intestinal tumorigenesis and modulates the tumor-immune microenvironment. Cell Host Microbe. 2013 Aug 14;14(2):207-15. doi: 10.1016/j.chom.2013.07.007.
PubMed 23954159
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Relation of Microbiome to Papillary Thyroid Microcarcinoma Development?
- ClinicalTrials.gov ID
- NCT04376203
- Acronym / sponsor ID
- Endocrine surgery Unit UOI 1
- Conditions
- Papillary Thyroid Microcarcinoma, Microbiome
- Keywords
- Microbiome, Papillary Thyroid Microcarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 27 Jul 2020 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 6 May 2020 (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.
It has been shown that gut microbiome and microbiome metabolism can regulate or control the initiation of a cancer process. To the best of the investigators knowledge, no study has directly shown the relationship of the thyroid microcarcinoma to the human microbiome. In this work, the aim is to detect the microbiome in peripheral blood in a patient with a thyroid gland carcinoma, and to correlate it with the disease, compared to the microbiome of a group of patients who did not find another thyroid gland carcinoma
Detailed description
Measurements of biological markers and tumor cell motility may be useful in predicting early whether a papillary thyroid microcarcinoma (PTMC) will develop to invasive carcinoma. Ideally, patients at high risk of progression may undergo immediate surgery instead of active surveillance and those with a very low likelihood of tumor progression may be included in an active surveillance protocol. Future research should focus on the development of new predictive early markers of papillary thyroid carcinoma during patient follow-up. From the above, it is clear the need to develop a new marker that raises the suspicion of possible thyroid microcarcinoma, if it is not preoperatively detected by the needle biopsy method and the patient has the indication for surgery for another benign thyroid disease. To date, there are no absolute biological and clinical parameters distinguishing a low risk from a high risk PTMC. If the fine needle aspiration shows stage V and VI Bethesda classification, and there is a high suspicion of PTMC, then questions such as the extent of the surgery, lobectomy or total thyroidectomy are beginning to be raised. The next dilemma is lymphadenectomy. The dilemma is greater if there are enlarged cervical lymph nodes (diameter over 1 cm in diameter of the small axis) and subsequently micromestases are confirmed. Another entity is when the cervical lymph nodes are not pathologically enlarged. This clinical situation is often emphasized as 60-80% of PTMC patients have metastases. By correlating a possible difference in the microbiome of a participants peripheral blood preoperatively, together with the imaging data, there may have been another marker of early PTMC detection and patient management planning respectively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Procedure: Thyroidectomyany patient with indications for thyroidectomy other than confirmed preoperative cancer |
| Thyroid microcarcinoma | – | Procedure: Thyroidectomyeither preoperative detection or random finding after thyroidectomy of another indication. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with indication for surgery for thyroid disease
Key inclusion criteria (1 listed)
- Patients who are going to have surgery for some thyroid disease, benign or malignant
Key exclusion criteria (4 listed)
- Recent, less than 3 months, infection of any system
- Receiving antibiotic or antiviral medication in the previous trimester
- Patient with chronic virus or bacterial infection
- Patient with dermatological disease
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 |
|---|---|---|
| ThyroidectomyTypical Thyroidectomy | Procedure or surgery | Control, Thyroid microcarcinoma |
Primary outcome
Type of microbiome in peripheral blood sample of a patient with papillary thyroid microcarcinoma
Time frame: preoperatively periferal blood collection, perioperatively periferal blood colection
Microbiome in a sample of peripheral blood in a patient with PTMC and to correlate it with the disease as a diagnostic marker compared to patients without any type of thyroid cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Background: PubMed 21624126Caporaso JG, Lauber CL, Costello EK, Berg-Lyons D, Gonzalez A, Stombaugh J, Knights D, Gajer P, Ravel J, Fierer N, Gordon JI, Knight R. Moving pictures of the human microbiome. Genome Biol. 2011;12(5):R50. doi: 10.1186/gb-2011-12-5-r50.
- Background: PubMed 30214283Choi JB, Lee WK, Lee SG, Ryu H, Lee CR, Kang SW, Jeong JJ, Nam KH, Lee EJ, Chung WY, Jo YS, Lee J. Long-term oncologic outcomes of papillary thyroid microcarcinoma according to the presence of clinically apparent lymph node metastasis: a large retrospective analysis of 5,348 patients. Cancer Manag Res. 2018 Aug 27;10:2883-2891. doi: 10.2147/CMAR.S173853. eCollection 2018.
- Background: PubMed 24336217David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
- Background: PubMed 30565661Feng J, Zhao F, Sun J, Lin B, Zhao L, Liu Y, Jin Y, Li S, Li A, Wei Y. Alterations in the gut microbiota and metabolite profiles of thyroid carcinoma patients. Int J Cancer. 2019 Jun 1;144(11):2728-2745. doi: 10.1002/ijc.32007. Epub 2018 Dec 24.
- Background: PubMed 17699621Frank DN, St Amand AL, Feldman RA, Boedeker EC, Harpaz N, Pace NR. Molecular-phylogenetic characterization of microbial community imbalances in human inflammatory bowel diseases. Proc Natl Acad Sci U S A. 2007 Aug 21;104(34):13780-5. doi: 10.1073/pnas.0706625104. Epub 2007 Aug 15.
- Background: PubMed 24629344Gevers D, Kugathasan S, Denson LA, Vazquez-Baeza Y, Van Treuren W, Ren B, Schwager E, Knights D, Song SJ, Yassour M, Morgan XC, Kostic AD, Luo C, Gonzalez A, McDonald D, Haberman Y, Walters T, Baker S, Rosh J, Stephens M, Heyman M, Markowitz J, Baldassano R, Griffiths A, Sylvester F, Mack D, Kim S, Crandall W, Hyams J, Huttenhower C, Knight R, Xavier RJ. The treatment-naive microbiome in new-onset Crohn's disease. Cell Host Microbe. 2014 Mar 12;15(3):382-392. doi: 10.1016/j.chom.2014.02.005.
- Background: PubMed 21407241Grice EA, Segre JA. The skin microbiome. Nat Rev Microbiol. 2011 Apr;9(4):244-53. doi: 10.1038/nrmicro2537.
- Background: PubMed 19478181Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
- Background: PubMed 26489866Hannigan GD, Meisel JS, Tyldsley AS, Zheng Q, Hodkinson BP, SanMiguel AJ, Minot S, Bushman FD, Grice EA. The human skin double-stranded DNA virome: topographical and temporal diversity, genetic enrichment, and dynamic associations with the host microbiome. mBio. 2015 Oct 20;6(5):e01578-15. doi: 10.1128/mBio.01578-15.
- Background: PubMed 2914297Hedinger C, Williams ED, Sobin LH. The WHO histological classification of thyroid tumors: a commentary on the second edition. Cancer. 1989 Mar 1;63(5):908-11. doi: 10.1002/1097-0142(19890301)63:53.0.co;2-i.
- Background: PubMed 30263008Ishaq HM, Mohammad IS, Shahzad M, Ma C, Raza MA, Wu X, Guo H, Shi P, Xu J. Molecular Alteration Analysis of Human Gut Microbial Composition in Graves' disease Patients. Int J Biol Sci. 2018 Sep 7;14(11):1558-1570. doi: 10.7150/ijbs.24151. eCollection 2018.
- Background: PubMed 31146753Kaliszewski K, Diakowska D, Wojtczak B, Forkasiewicz Z, Pupka D, Nowak L, Rudnicki J. Which papillary thyroid microcarcinoma should be treated as "true cancer" and which as "precancer"? World J Surg Oncol. 2019 May 31;17(1):91. doi: 10.1186/s12957-019-1638-0.
- Individual participant dataSharing planned: Yes. all data
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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.
KONSTANTINOS VLACHOS, Associate Professor of Surgery study chair
University of Ioannina
IOANNIS KOUTELIDAKIS, Associate Professor of Surgery study chair
Aristotle University Of Thessaloniki
Questions about this trial
What is this clinical trial studying?
An observational study of Papillary Thyroid Microcarcinoma and Microbiome, run by University of Ioannina.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact STEFANOS STEFANOU, Specialist (+306944983533, stefanousurgery@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of microbiome in peripheral blood sample of a patient with papillary thyroid microcarcinoma (time frame: preoperatively periferal blood collection, perioperatively periferal blood colection). 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 NCT04376203, which also lists 31 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 30 Jun 2020.