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Prevention study for Pancreatic Cyst
Official title Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection
ClinicalTrials.gov ID: NCT06320990
What this study is testing
What is Tamoxifen 20mg?
Tamoxifen 20mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pancreatic cyst.
Also referred to as Soltamox.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Pancreatic mucinous cystic neoplasm (MCN) is a precursor to invasive pancreatic adenocarcinoma which occurs almost exclusively in females in their 5th-7th decade. Currently the only option for MCN treatment and prevention of invasive pancreatic ductal adenocarcinoma (PDA) is oncologic resection.
- Phase 1: an early, usually small safety study
- Time commitment: about 24 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Age ≥ 19 years
- Clinically diagnosed pre-invasive pancreatic mucinous cystic neoplasm (MCN), measurable by cross-sectional imaging
- Surgical resection of the lesion is not planned due to cyst features, patient factors or patient preference
- Females of reproductive potential and males with partners of reproductive potential must agree to employ two methods contraception throughout the...
- Estimated glomerular filtration rate (eGFR) \> 30mL/min/1.73m2
You likely can't join if
- Presence of invasive pancreatic adenocarcinoma or high-grade dysplasia
- Presence of a solid component or mural nodule, main pancreatic duct dilation or abrupt caliber change, obstructive jaundice, lymphadenopathy
- Current or prior use of tamoxifen or another estrogen antagonist including, but not limited to, clomifene, raloxifene, fulvestrant, anastrazole...
- Current or planned use of hormonal treatments including estrogen, progesterone, androgens, hormone replacement therapy or other types of hormonal...
- Contraindications to tamoxifen include:
- Pregnancy or nursing
See the full eligibility criteria
- Age ≥ 19 years
- Clinically diagnosed pre-invasive pancreatic mucinous cystic neoplasm (MCN), measurable by cross-sectional imaging
- Surgical resection of the lesion is not planned due to cyst features, patient factors or patient preference
- Females of reproductive potential and males with partners of reproductive potential must agree to employ two methods contraception throughout the study and for up to 3 months following treatment. Non-child-bearing...
- Estimated glomerular filtration rate (eGFR) \> 30mL/min/1.73m2
- Willing and able to provide informed consent to and abide by the protocol
- Presence of invasive pancreatic adenocarcinoma or high-grade dysplasia
- Presence of a solid component or mural nodule, main pancreatic duct dilation or abrupt caliber change, obstructive jaundice, lymphadenopathy
- Current or prior use of tamoxifen or another estrogen antagonist including, but not limited to, clomifene, raloxifene, fulvestrant, anastrazole; people who have previously used an estrogen antagonist are eligible...
- Current or planned use of hormonal treatments including estrogen, progesterone, androgens, hormone replacement therapy or other types of hormonal contraceptives including implants and depot injections...
- Contraindications to tamoxifen include:
- Pregnancy or nursing
- Known allergy or hypersensitivity to tamoxifen
- Cataracts which affect visual acuity (ie. symptomatic)
- Retinopathy which affects visual acuity (ie. symptomatic)
- Current warfarin use
- History of deep vein thrombosis or pulmonary embolism or other condition which, in the opinion of the investigator, may significantly increase the individual's risk of venous thromboembolism
- History of stroke
- Known endometrial hyperplasia or personal history of endometrial carcinoma, uterine sarcoma and uterine carcinosarcoma
- History of intestinal disease or major gastric surgery likely to alter absorption of tamoxifen or inability to swallow oral medications
- Uncontrolled illness including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina or uncontrolled cardiac arrhythmias, or other conditions...
- Elective surgery planned for the study period
- Participation in another clinical study with an investigational product during the last 28 days
- Any participant, in the opinion of the investigator, who will not be able to tolerate treatment, or the participant is unsuitable to participate in the study and is unlikely to comply with study procedures, restrictions...
The study team makes the final eligibility decision.
Where it's taking place
- Omaha, Nebraska, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.