Rectal CancerNCT04223102
Microbiome and Rectal Cancer
A study testing Tissue collection in people with Rectal Cancer and Locally Advanced Malignant Neoplasm, run by University of South Florida at 3 sites in United States.
Trial summary
The purpose of our study is to determine if an association exists between the microbiome of those with rectal adenocarcinoma who are complete pathologic responders and those who have a partial or no response to neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Locally Advanced Malignant Neoplasm
- What is being tested?
- Tissue collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Feb 2020to Jun 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Locally Advanced Rectal Adenocarcinoma (T3)
- Standard 5FU based chemoradiation
- Total Neoadjuvant Therapy per OPRA protocol guidelines
Who cannot join
- Age < 18 years
- Stage I or Stage IV rectal adenocarcinoma
- Rectal cancer other than adenocarcinoma
- Genetically associated cancer (HNPCC, FAP etc.) or highly suspicious for genetically associated cancer
- Prior history of rectal adenocarcinoma (i.e. recurrent colorectal adenocarcinoma)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tampa General Hospital
Tampa, Florida, 33606
University of South Florida - South Tampa Campus
Tampa, Florida, 33606
University of South Florida
Tampa, Florida, 33612
About this study
Official title: Rectal Microbiome Variability Among Rectal Cancer Cohorts Including Complete Clinical Responders, Pathologic Responders, and Early Recurrence
The purpose of our study is to determine if an association exists between the microbiome of those with rectal adenocarcinoma who are complete pathologic responders and those who have a partial or no response to neoadjuvant therapy.
Read the detailed description
This study will help to further elucidate the association of bacteria with rectal cancer, while also characterizing the genes associated with that risk. Furthermore it will attempt to better understand which patients may have an optimal response to neoadjuvant chemoradiation allowing for possible predictive metagenomics evaluation, investigators may be able to augment treatments as well as provide recommendations for the success and cost effectiveness of cancer care.
- Conditions
- Rectal Cancer, Locally Advanced Malignant Neoplasm
- Being tested
- Tissue collection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue collectionProcedure or surgery
A flexible sigmoidoscopy is a procedure in which a flexible tubularized camera approximately 1 cm in diameter is inserted into the anus and advanced proximally to the sigmoid colon (approximately 20 cm). At that time a rectal biopsy of the tumor will be obtained as well as a sample from >5cm proximal to the tumor, with a separate biopsy forcep. Tattoo injection, as standard of care, will be performed within 1 cm distal to the tumor to identify the location in the future or for surgical intervention. If there is inability to get proximal to the tumor then a location at least 5 cm adjacent in any direction will be sufficient so long as it is grossly normal appearing.
| Study group | Role | What they receive |
|---|---|---|
| Tissue collection | Other | Tissue collection Receives: Procedure: Tissue collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
16s rRNA gene sequencing to study bacterial phylogeny and taxonomy
16s rRNA sequencing from biopsy specimens
Measured: 5 years
Secondary outcomes (1)
rectal microbiota to study bacteria strains
rectal microbiota - bacteria strains from biopsy specimens
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start18 Feb 2020
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James R Williams, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223102
- Sponsor's protocol ID
- Pro00040924
- Status last verified
- Jul 2023
- First submitted
- 12 Nov 2019
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
NIH HMP Working Group; Peterson J, Garges S, Giovanni M, McInnes P, Wang L, Schloss JA, Bonazzi V, McEwen JE, Wetterstrand KA, Deal C, Baker CC, Di Francesco V, Howcroft TK, Karp RW, Lunsford RD, Wellington CR, Belachew T, Wright M, Giblin C, David H, Mills M, Salomon R, Mullins C, Akolkar B, Begg L, Davis C, Grandison L, Humble M, Khalsa J, Little AR, Peavy H, Pontzer C, Portnoy M, Sayre MH, Starke-Reed P, Zakhari S, Read J, Watson B, Guyer M. The NIH Human Microbiome Project. Genome Res. 2009 Dec;19(12):2317-23. doi: 10.1101/gr.096651.109. Epub 2009 Oct 9.
PubMed 19819907Smith JJ, Chow OS, Gollub MJ, Nash GM, Temple LK, Weiser MR, Guillem JG, Paty PB, Avila K, Garcia-Aguilar J; Rectal Cancer Consortium. Organ Preservation in Rectal Adenocarcinoma: a phase II randomized controlled trial evaluating 3-year disease-free survival in patients with locally advanced rectal cancer treated with chemoradiation plus induction or consolidation chemotherapy, and total mesorectal excision or nonoperative management. BMC Cancer. 2015 Oct 23;15:767. doi: 10.1186/s12885-015-1632-z.
PubMed 26497495Maas M, Nelemans PJ, Valentini V, Das P, Rodel C, Kuo LJ, Calvo FA, Garcia-Aguilar J, Glynne-Jones R, Haustermans K, Mohiuddin M, Pucciarelli S, Small W Jr, Suarez J, Theodoropoulos G, Biondo S, Beets-Tan RG, Beets GL. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol. 2010 Sep;11(9):835-44. doi: 10.1016/S1470-2045(10)70172-8. Epub 2010 Aug 6.
PubMed 20692872Smith JD, Ruby JA, Goodman KA, Saltz LB, Guillem JG, Weiser MR, Temple LK, Nash GM, Paty PB. Nonoperative management of rectal cancer with complete clinical response after neoadjuvant therapy. Ann Surg. 2012 Dec;256(6):965-72. doi: 10.1097/SLA.0b013e3182759f1c.
PubMed 23154394Gerassy-Vainberg S, Blatt A, Danin-Poleg Y, Gershovich K, Sabo E, Nevelsky A, Daniel S, Dahan A, Ziv O, Dheer R, Abreu MT, Koren O, Kashi Y, Chowers Y. Radiation induces proinflammatory dysbiosis: transmission of inflammatory susceptibility by host cytokine induction. Gut. 2018 Jan;67(1):97-107. doi: 10.1136/gutjnl-2017-313789. Epub 2017 Apr 24.
PubMed 28438965Araujo-Perez F, McCoy AN, Okechukwu C, Carroll IM, Smith KM, Jeremiah K, Sandler RS, Asher GN, Keku TO. Differences in microbial signatures between rectal mucosal biopsies and rectal swabs. Gut Microbes. 2012 Nov-Dec;3(6):530-5. doi: 10.4161/gmic.22157. Epub 2012 Oct 11.
PubMed 23060016Peters BA, Wu J, Pei Z, Yang L, Purdue MP, Freedman ND, Jacobs EJ, Gapstur SM, Hayes RB, Ahn J. Oral Microbiome Composition Reflects Prospective Risk for Esophageal Cancers. Cancer Res. 2017 Dec 1;77(23):6777-6787. doi: 10.1158/0008-5472.CAN-17-1296.
PubMed 29196415Sanapareddy N, Legge RM, Jovov B, McCoy A, Burcal L, Araujo-Perez F, Randall TA, Galanko J, Benson A, Sandler RS, Rawls JF, Abdo Z, Fodor AA, Keku TO. Increased rectal microbial richness is associated with the presence of colorectal adenomas in humans. ISME J. 2012 Oct;6(10):1858-68. doi: 10.1038/ismej.2012.43. Epub 2012 May 24.
PubMed 22622349Xu K, Jiang B. Analysis of Mucosa-Associated Microbiota in Colorectal Cancer. Med Sci Monit. 2017 Sep 14;23:4422-4430. doi: 10.12659/msm.904220.
PubMed 28904330Kwong TNY, Wang X, Nakatsu G, Chow TC, Tipoe T, Dai RZW, Tsoi KKK, Wong MCS, Tse G, Chan MTV, Chan FKL, Ng SC, Wu JCY, Wu WKK, Yu J, Sung JJY, Wong SH. Association Between Bacteremia From Specific Microbes and Subsequent Diagnosis of Colorectal Cancer. Gastroenterology. 2018 Aug;155(2):383-390.e8. doi: 10.1053/j.gastro.2018.04.028. Epub 2018 May 3.
PubMed 29729257Kasai C, Sugimoto K, Moritani I, Tanaka J, Oya Y, Inoue H, Tameda M, Shiraki K, Ito M, Takei Y, Takase K. Comparison of human gut microbiota in control subjects and patients with colorectal carcinoma in adenoma: Terminal restriction fragment length polymorphism and next-generation sequencing analyses. Oncol Rep. 2016 Jan;35(1):325-33. doi: 10.3892/or.2015.4398. Epub 2015 Nov 4.
PubMed 26549775Yoon H, Kim N, Park JH, Kim YS, Lee J, Kim HW, Choi YJ, Shin CM, Park YS, Lee DH, Jung HC. Comparisons of Gut Microbiota Among Healthy Control, Patients With Conventional Adenoma, Sessile Serrated Adenoma, and Colorectal Cancer. J Cancer Prev. 2017 Jun;22(2):108-114. doi: 10.15430/JCP.2017.22.2.108. Epub 2017 Jun 30.
PubMed 28698865Ahn J, Sinha R, Pei Z, Dominianni C, Wu J, Shi J, Goedert JJ, Hayes RB, Yang L. Human gut microbiome and risk for colorectal cancer. J Natl Cancer Inst. 2013 Dec 18;105(24):1907-11. doi: 10.1093/jnci/djt300. Epub 2013 Dec 6.
PubMed 24316595Chen W, Liu F, Ling Z, Tong X, Xiang C. Human intestinal lumen and mucosa-associated microbiota in patients with colorectal cancer. PLoS One. 2012;7(6):e39743. doi: 10.1371/journal.pone.0039743. Epub 2012 Jun 28.
PubMed 22761885Jones RB, Zhu X, Moan E, Murff HJ, Ness RM, Seidner DL, Sun S, Yu C, Dai Q, Fodor AA, Azcarate-Peril MA, Shrubsole MJ. Inter-niche and inter-individual variation in gut microbial community assessment using stool, rectal swab, and mucosal samples. Sci Rep. 2018 Mar 7;8(1):4139. doi: 10.1038/s41598-018-22408-4.
PubMed 29515151
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Microbiome Variability Among Rectal Cancer Cohorts Including Complete Clinical Responders, Pathologic Responders, and Early Recurrence
- ClinicalTrials.gov ID
- NCT04223102
- Acronym / sponsor ID
- Pro00040924
- Conditions
- Rectal Cancer, Locally Advanced Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Jan 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.
The purpose of our study is to determine if an association exists between the microbiome of those with rectal adenocarcinoma who are complete pathologic responders and those who have a partial or no response to neoadjuvant therapy.
Detailed description
This study will help to further elucidate the association of bacteria with rectal cancer, while also characterizing the genes associated with that risk. Furthermore it will attempt to better understand which patients may have an optimal response to neoadjuvant chemoradiation allowing for possible predictive metagenomics evaluation, investigators may be able to augment treatments as well as provide recommendations for the success and cost effectiveness of cancer care.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tissue collection | Other | Procedure: Tissue collectionTissue collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Locally Advanced Rectal Adenocarcinoma (T3)
- Standard 5FU based chemoradiation
- Total Neoadjuvant Therapy per OPRA protocol guidelines
Key exclusion criteria (5 listed)
- Age < 18 years
- Stage I or Stage IV rectal adenocarcinoma
- Rectal cancer other than adenocarcinoma
- Genetically associated cancer (HNPCC, FAP etc.) or highly suspicious for genetically associated cancer
- Prior history of rectal adenocarcinoma (i.e. recurrent colorectal adenocarcinoma)
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 |
|---|---|---|
| Tissue collectionA flexible sigmoidoscopy is a procedure in which a flexible tubularized camera approximately 1 cm in diameter is inserted into the anus and advanced proximally to the sigmoid colon (approximately 20 cm). At that time a rectal biopsy of the tumor will be obtained as well as a sample from >5cm proximal to the tumor, with a separate biopsy forcep. Tattoo injection, as standard of care, will be performed within 1 cm distal to the tumor to identify the location in the future or for surgical intervention. If there is inability to get proximal to the tumor then a location at least 5 cm adjacent in any direction will be sufficient so long as it is grossly normal appearing. | Procedure or surgery | Tissue collection |
Primary outcome
16s rRNA gene sequencing to study bacterial phylogeny and taxonomy
Time frame: 5 years
16s rRNA sequencing from biopsy specimens
1 secondary outcome
rectal microbiota to study bacteria strains
Time frame: 5 years
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 2 Aug 2023.
- Background: PubMed 19819907NIH HMP Working Group; Peterson J, Garges S, Giovanni M, McInnes P, Wang L, Schloss JA, Bonazzi V, McEwen JE, Wetterstrand KA, Deal C, Baker CC, Di Francesco V, Howcroft TK, Karp RW, Lunsford RD, Wellington CR, Belachew T, Wright M, Giblin C, David H, Mills M, Salomon R, Mullins C, Akolkar B, Begg L, Davis C, Grandison L, Humble M, Khalsa J, Little AR, Peavy H, Pontzer C, Portnoy M, Sayre MH, Starke-Reed P, Zakhari S, Read J, Watson B, Guyer M. The NIH Human Microbiome Project. Genome Res. 2009 Dec;19(12):2317-23. doi: 10.1101/gr.096651.109. Epub 2009 Oct 9.
- Background: PubMed 26497495Smith JJ, Chow OS, Gollub MJ, Nash GM, Temple LK, Weiser MR, Guillem JG, Paty PB, Avila K, Garcia-Aguilar J; Rectal Cancer Consortium. Organ Preservation in Rectal Adenocarcinoma: a phase II randomized controlled trial evaluating 3-year disease-free survival in patients with locally advanced rectal cancer treated with chemoradiation plus induction or consolidation chemotherapy, and total mesorectal excision or nonoperative management. BMC Cancer. 2015 Oct 23;15:767. doi: 10.1186/s12885-015-1632-z.
- Background: PubMed 20692872Maas M, Nelemans PJ, Valentini V, Das P, Rodel C, Kuo LJ, Calvo FA, Garcia-Aguilar J, Glynne-Jones R, Haustermans K, Mohiuddin M, Pucciarelli S, Small W Jr, Suarez J, Theodoropoulos G, Biondo S, Beets-Tan RG, Beets GL. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol. 2010 Sep;11(9):835-44. doi: 10.1016/S1470-2045(10)70172-8. Epub 2010 Aug 6.
- Background: PubMed 23154394Smith JD, Ruby JA, Goodman KA, Saltz LB, Guillem JG, Weiser MR, Temple LK, Nash GM, Paty PB. Nonoperative management of rectal cancer with complete clinical response after neoadjuvant therapy. Ann Surg. 2012 Dec;256(6):965-72. doi: 10.1097/SLA.0b013e3182759f1c.
- Background: PubMed 28438965Gerassy-Vainberg S, Blatt A, Danin-Poleg Y, Gershovich K, Sabo E, Nevelsky A, Daniel S, Dahan A, Ziv O, Dheer R, Abreu MT, Koren O, Kashi Y, Chowers Y. Radiation induces proinflammatory dysbiosis: transmission of inflammatory susceptibility by host cytokine induction. Gut. 2018 Jan;67(1):97-107. doi: 10.1136/gutjnl-2017-313789. Epub 2017 Apr 24.
- Background: PubMed 23060016Araujo-Perez F, McCoy AN, Okechukwu C, Carroll IM, Smith KM, Jeremiah K, Sandler RS, Asher GN, Keku TO. Differences in microbial signatures between rectal mucosal biopsies and rectal swabs. Gut Microbes. 2012 Nov-Dec;3(6):530-5. doi: 10.4161/gmic.22157. Epub 2012 Oct 11.
- Results publication: PubMed 29196415Peters BA, Wu J, Pei Z, Yang L, Purdue MP, Freedman ND, Jacobs EJ, Gapstur SM, Hayes RB, Ahn J. Oral Microbiome Composition Reflects Prospective Risk for Esophageal Cancers. Cancer Res. 2017 Dec 1;77(23):6777-6787. doi: 10.1158/0008-5472.CAN-17-1296.
- Results publication: PubMed 22622349Sanapareddy N, Legge RM, Jovov B, McCoy A, Burcal L, Araujo-Perez F, Randall TA, Galanko J, Benson A, Sandler RS, Rawls JF, Abdo Z, Fodor AA, Keku TO. Increased rectal microbial richness is associated with the presence of colorectal adenomas in humans. ISME J. 2012 Oct;6(10):1858-68. doi: 10.1038/ismej.2012.43. Epub 2012 May 24.
- Results publication: PubMed 28904330Xu K, Jiang B. Analysis of Mucosa-Associated Microbiota in Colorectal Cancer. Med Sci Monit. 2017 Sep 14;23:4422-4430. doi: 10.12659/msm.904220.
- Results publication: PubMed 29729257Kwong TNY, Wang X, Nakatsu G, Chow TC, Tipoe T, Dai RZW, Tsoi KKK, Wong MCS, Tse G, Chan MTV, Chan FKL, Ng SC, Wu JCY, Wu WKK, Yu J, Sung JJY, Wong SH. Association Between Bacteremia From Specific Microbes and Subsequent Diagnosis of Colorectal Cancer. Gastroenterology. 2018 Aug;155(2):383-390.e8. doi: 10.1053/j.gastro.2018.04.028. Epub 2018 May 3.
- Results publication: PubMed 26549775Kasai C, Sugimoto K, Moritani I, Tanaka J, Oya Y, Inoue H, Tameda M, Shiraki K, Ito M, Takei Y, Takase K. Comparison of human gut microbiota in control subjects and patients with colorectal carcinoma in adenoma: Terminal restriction fragment length polymorphism and next-generation sequencing analyses. Oncol Rep. 2016 Jan;35(1):325-33. doi: 10.3892/or.2015.4398. Epub 2015 Nov 4.
- Results publication: PubMed 28698865Yoon H, Kim N, Park JH, Kim YS, Lee J, Kim HW, Choi YJ, Shin CM, Park YS, Lee DH, Jung HC. Comparisons of Gut Microbiota Among Healthy Control, Patients With Conventional Adenoma, Sessile Serrated Adenoma, and Colorectal Cancer. J Cancer Prev. 2017 Jun;22(2):108-114. doi: 10.15430/JCP.2017.22.2.108. Epub 2017 Jun 30.
- Individual participant dataSharing planned: No
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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.
James R Williams, MD principal investigator
University of South Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue collection in people with Rectal Cancer and Locally Advanced Malignant Neoplasm, run by University of South Florida at 3 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
16s rRNA gene sequencing to study bacterial phylogeny and taxonomy (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04223102, which also lists 35 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 2 Aug 2023.