Familial Adenomatous PolyposisNCT04674228
Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01
An observational study of Familial Adenomatous Polyposis, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
This study reviews post study clinical endoscopy reports in follow up to patients who participated in MAY2016-07-01 with weekly erlotinib for familial adenomatous polyposis. Reviewing follow up medical records may help researchers examine the extent of rapid progression of familiar adenomatous polyposis disease burden… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Familial Adenomatous Polyposis
- What is being tested?
- Electronic Health Record Review
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 May 2021to 17 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants in MAY2016-07-01 Phase II Trial of Weekly Erlotinib Dosing to Reduce Duodenal Polyp Burden Associated with Familial Adenomatous Polyposis
Who may be able to join
- MAY2016-07-01 study participants for whom medical records are available and accessible
Who cannot join
- MAY2016-07-01 study participants who have opted out of medical records reviews or for whom consent for medical record review cannot be confirmed/documented
Trial locations and contacts
2 sites in 1 country.
United States2 sites
M D Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01 Weekly Erlotinib for Familial Adenomatous Polyposis
This study reviews post study clinical endoscopy reports in follow up to patients who participated in MAY2016-07-01 with weekly erlotinib for familial adenomatous polyposis. Reviewing follow up medical records may help researchers examine the extent of rapid progression of familiar adenomatous polyposis disease burden after discontinuation of weekly erlotinib.
Read the detailed description
PRIMARY OBJECTIVE:
- To review clinical endoscopy reports, pathology reports, and other medical records related to standard-of-care endoscopic evaluations for all participants in the parent study, MAY2016-07-01, to determine the extent of reports of rapid progression of recurrent polyps after completion intervention and follow up under the parent protocol.
OUTLINE:
Patients who participated in MAY2016-07-01 undergo review of medical records.
- Conditions
- Familial Adenomatous Polyposis
- Being tested
- Electronic Health Record Review
- Medical subject headings
- Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Review of medical records
| Study group | Role | What they receive |
|---|---|---|
| Observational (medical record review) | Patients who participated in MAY2016-07-01 undergo review of medical records. Receives: Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of study participants exhibiting clinically significant progression of duodenal neoplasia after completion of study drug
Will be assessed by endoscopy.
Measured: At completion of study
Number of participants who underwent surgical resection
Will determine the number of participants who underwent surgical resection for management of advanced upper gastrointestinal (GI) neoplasia/cancer between the date of completion of intervention and 2/28/2021.
Measured: At completion of study
Number of participants who required endoscopic resection of advanced upper gastrointestinal (GI) neoplasms
Measured: At completion of study
Secondary outcomes (1)
Number of participants with evidence of progression of upper GI disease
Will be calculated by increase in Spigelman stage.
Measured: At completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start7 May 2021
- Primary completion28 Oct 2021
- Study completion17 May 2022
Why it stopped: This particular part of the study could not be completed as endoscopy reports post completion of erlotinib trial were distributed across community and other hos
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Adenomatous PolyposisStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Niloy J Samadder, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674228
- Sponsor's protocol ID
- NCI-2020-13238
- Other IDs
- NCI-2020-13238, N01-CN-2012-00042, MAY2016-07-01F, MAY2016-07-01F, N01CN00042, P30CA015083
- Status last verified
- Jan 2024
- First submitted
- 17 Dec 2020
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01 Weekly Erlotinib for Familial Adenomatous Polyposis
- ClinicalTrials.gov ID
- NCT04674228
- Acronym / sponsor ID
- NCI-2020-13238
- Conditions
- Familial Adenomatous Polyposis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This particular part of the study could not be completed as endoscopy reports post completion of erlotinib trial were distributed across community and other hos
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 7 May 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 19 Dec 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.
This study reviews post study clinical endoscopy reports in follow up to patients who participated in MAY2016-07-01 with weekly erlotinib for familial adenomatous polyposis. Reviewing follow up medical records may help researchers examine the extent of rapid progression of familiar adenomatous polyposis disease burden after discontinuation of weekly erlotinib.
Detailed description
PRIMARY OBJECTIVE:
- To review clinical endoscopy reports, pathology reports, and other medical records related to standard-of-care endoscopic evaluations for all participants in the parent study, MAY2016-07-01, to determine the extent of reports of rapid progression of recurrent polyps after completion intervention and follow up under the parent protocol.
OUTLINE:
Patients who participated in MAY2016-07-01 undergo review of medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (medical record review) | – | Other: Electronic Health Record ReviewPatients who participated in MAY2016-07-01 undergo review of medical records. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants in MAY2016-07-01 Phase II Trial of Weekly Erlotinib Dosing to Reduce Duodenal Polyp Burden Associated with Familial Adenomatous Polyposis
Key inclusion criteria (1 listed)
- MAY2016-07-01 study participants for whom medical records are available and accessible
Key exclusion criteria (1 listed)
- MAY2016-07-01 study participants who have opted out of medical records reviews or for whom consent for medical record review cannot be confirmed/documented
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 |
|---|---|---|
| Electronic Health Record ReviewReview of medical records | Other | Observational (medical record review) |
Primary outcome
Number of study participants exhibiting clinically significant progression of duodenal neoplasia after completion of study drug
Time frame: At completion of study
Will be assessed by endoscopy.
Number of participants who underwent surgical resection
Time frame: At completion of study
Will determine the number of participants who underwent surgical resection for management of advanced upper gastrointestinal (GI) neoplasia/cancer between the date of completion of intervention and 2/28/2021.
Number of participants who required endoscopic resection of advanced upper gastrointestinal (GI) neoplasms
Time frame: At completion of study
1 secondary outcome
Number of participants with evidence of progression of upper GI disease
Time frame: At completion of study
Results and safety
The study was stopped early (reason given: This particular part of the study could not be completed as endoscopy reports post completion of erlotinib trial were distributed across community and other hos). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Related trials for Familial Adenomatous Polyposis
RecruitingPhase 1
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Colorectal Adenomatous Polyp, Colorectal Carcinoma
RecruitingPhase 1/2
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Cancer, Colorectal Cancer
Enrolling by invitation
Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
FAP, Familial Adenomatous Polyposis
RecruitingPhase 2
An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis
Colorectal Carcinoma, Familial Adenomatous Polyposis
Not yet recruitingPhase 1
A Safety Study of ST316 in Participants With Familial Adenomatous Polyposis (FAP).
Familial Adenomatous Polyposis (FAP)
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.
Niloy J Samadder principal investigator
Mayo Clinic in Rochester
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 Familial Adenomatous Polyposis, run by National Cancer Institute (NCI) 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 Jun 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?
The study was stopped early (reason given: This particular part of the study could not be completed as endoscopy reports post completion of erlotinib trial were distributed across community and other hos). Results are not available in the source record.
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?
Number of study participants exhibiting clinically significant progression of duodenal neoplasia after completion of study drug (time frame: At completion of study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2026.